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FDA Import Alert 16-120: Detention of Non-Compliant Fish Products

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Published January 14th, 2026
Detected March 1st, 2026
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Summary

The FDA has updated Import Alert 16-120, revising guidance for field personnel regarding the detention without physical examination (DWPE) of fish and fishery products from foreign processors not in compliance with the Seafood HACCP regulation. The update includes changes to the title, reason for alert, and guidance sections, incorporating foreign remote regulatory assessments as a compliance verification method.

What changed

The FDA's Import Alert 16-120 has been updated to reflect current guidance on the detention without physical examination (DWPE) of fish and fishery products from foreign processors failing to comply with the Seafood HACCP regulation (21 CFR Part 123). The revision, effective January 14, 2026, modifies the alert's title, reason, and guidance sections, explicitly including foreign remote regulatory assessments (FRRA) as a method for FDA to assess compliance. Products from non-compliant foreign processors may be detained until compliance is demonstrated.

Importers and exporters of fish and fishery products should be aware of this updated guidance. Foreign processors identified in the Red List of this alert may face DWPE for their shipments. To be removed from the Red List, firms must provide documentation demonstrating resolution of HACCP compliance issues, as detailed in the FDA's Regulatory Procedures Manual. Failure to comply with the Seafood HACCP regulation renders products adulterated under the Federal Food, Drug, and Cosmetic Act.

What to do next

  1. Review updated Import Alert 16-120 for specific requirements regarding foreign processors and seafood HACCP compliance.
  2. Ensure all imported fish and fishery products and their foreign processors comply with 21 CFR Part 123.
  3. Consult the FDA's Regulatory Procedures Manual (Chapter 9-8) for detailed procedures on removal from DWPE if a processor is listed on the Red List.

Penalties

Detention without physical examination of imported fish and fishery products. Products may be considered adulterated under the Federal Food, Drug, and Cosmetic Act.

Source document (simplified)

  • Home
  • Import Program
  • Import Alerts
  • Imports Alerts by Number (Note: This import alert represents the Agency's current guidance to FDA field personnel regarding the manufacturer(s) and/or products(s) at issue. It does not create or confer any rights for or on any person, and does not operate to bind FDA or the public).

Import Alert # 16-120 Published Date: 02/27/2026 Type: DWPE

Import Alert Name:

"Detention Without Physical Examination of Fish and Fishery Products from Foreign Processors (Mfrs.) Not in Compliance with Seafood HACCP Regulation"

Reason for Alert:

Note: The revision of this Import Alert (IA) dated 01/14/2026 updates the title, reason for alert, and guidance section. Changes to the import alert are bracketed by asterisks (***).

***On December 18, 1997, 21 CFR Part 123 (generally referred to as the seafood HACCP regulation) became effective. Under this regulation, all fish and fishery products, whether foreign or domestic in origin, are required to be prepared, packed and held in facilities operating under mandatory HACCP requirements for safe and sanitary processing. Sanitation controls are to be included within the HACCP plan or monitored in accordance 21 CFR 123.11 (b) to comply with the 21 CFR 123.6 (f). Additionally, compliance with Current Good Manufacturing Practice (CGMP) in 21 CFR 117 is required by 21 CFR 123.5.

In accordance with 21 CFR 123.6 (g), failure of a processor of fish or fishery products to have and implement a HACCP plan that complies with this section or otherwise operate in accordance with the requirements of Part 123, renders the fish or fishery products adulterated within the meaning of section 402 (a)(4) of the Federal Food, Drug and Cosmetic Act (the Act), 21 U.S.C. ? 342(a)(4).***

Foreign processors who fail to meet the requirements of 21 CFR Part 123 may have entries subject to detention without physical examination until such time as such documentation demonstrating compliance is provided, as described in "GUIDANCE" section of this import alert.

FDA might determine the foreign processor's compliance through inspection of the foreign processor, a foreign remote regulatory assessment (FRRA), inspection of an importer, review of import entry records, or through review of an importer's seafood product reconditioning proposal.

Guidance:

Divisions may detain without physical examination, fish and fishery products from foreign processors (manufacturers) identified in the Red List to this import alert.

Note: Divisions should refer to Compliance Program 7303.0844, "Import Seafood Products" for implementation guidance.

Detention Without Physical Examination (DWPE) may be indicated for a foreign processor/product(s) combination when HFP has determined that a foreign processor has failed to meet HACCP requirements for a specific product. DIO will coordinate with HFP for concurrence and addition to the Red List of this import alert.

Removal from Detention Without Physical Examination (REMOVE FROM RED LIST):

In order to remove a firm's product from the Red List, information should be provided to the Agency to adequately demonstrates that the firm has resolved the conditions that gave rise to the appearance of the violation. The purpose of this is so that the Agency will have confidence that future shipments/entries will be in compliance with the Federal Food Drug and Cosmetic Act (FD&C Act). For further guidance on removal from DWPE, refer to FDA?s Regulatory Procedures Manual (RPM), Chapter 9-8, ?Detention without Physical Examination (DWPE)?.

Foreign processors listed on the Red List to this import alert may be removed from that list by submitting documentation demonstrating that they are in compliance with the seafood HACCP regulation (21 CFR, Part 123). The foreign processor should provide a letter detailing its corrective actions, accompanied by documentation.

*** Examples of such documentation may include:
? HACCP plan
? Hazard analysis
? Process flow diagram with description of processing steps with times and temperatures
? Five days of critical control point monitoring records
? Five days of sanitation monitoring records
? Procedures
? Employee training records
? Photographs

21 CFR Part 123 and other resources can be found through links on FDA?s Seafood webpage. For assistance with creating your HACCP plan see Chapter 2 of FDA?s Fish and Fishery Products Hazards and Controls guidance and for sanitation monitoring see the Sanitation Control Procedures for Processing Fish and Fishery Products document. For seafood HACCP training and other resources see the Florida Sea Grant website.***

All relevant information supporting the request should be sent via email to:

Importalerts2@fda.hhs.gov

Requests for removal from DWPE under the Red List of this import alert will be referred by DIO to Human Foods Program/Division of Produce and Imports Enforcement/Imports Enforcement Branch for evaluation.

Questions or issues involving import operations or the submission of petitions for removal from DWPE should be addressed to OII/DIO (301) 796-0356 or Imports@fda.hhs.gov.

For technical and scientific questions unrelated to a ?live? entry, regarding adequacy of foreign processor HACCP documentation, contact HFP?s Office of Microbial Food Safety, Division of Seafood Safety at (240)402-2300 or via email to: SeafoodHACCP@fda.gov

Product Description:

Fish and Fishery Products

Charge:

The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Act in that it appears to have been prepared, packed or held under insanitary conditions whereby it may have been rendered injurious to health in that it appears to have been processed in violation of 21 CFR 123.6(a) and 123.8(a) [Adulteration, 402(a)(4)].

OASIS charge code: MFRHACCP

List of firms and their products subject to Detention without Physical Examination (DWPE) under this Import Alert (a.k.a. Red List)

BRAZIL

Atlantico Marinho Ltda Date Published : 03/13/2009 Rua Dona Arcelina de Oliveira, 444
, Imbiribeira, Recife,
BRAZIL 16 Y - - 08 Shark Fin, Fishery Products, n.e.c.
Date Published: 03/13/2009

Desc: dried shark fins Notes: 4/17/2003 CAMPASA CAMAROES DO PARA S/A Date Published : 03/13/2009 Rodovia Curuca Abade, Sn
, Curuca,
Para BRAZIL 16 A - - 51 Mahi Mahi
Date Published: 03/13/2009

Notes: 4/6/2005 Frigorifico Camlombe Ind E Com. Ltd Date Published : 03/13/2009 Ave Colombe 3010
, Rio De Janeiro,
BRAZIL 16 A - - 01 Anchovy
Date Published: 03/13/2009

Notes: 4/1/2005 16 A - - 05 Blue Fish
Date Published: 03/13/2009

Notes: 4/1/2005 16 A - - 07 Bonito
Date Published: 03/13/2009

Notes: 4/1/2005 16 A - - 21 Herring
Date Published: 03/13/2009

Notes: 4/1/2005 16 A - - 33 Sardines (Brisling, Sprats, Pilchards, Etc.)
Date Published: 03/13/2009

Notes: 4/1/2005 16 A - - 37 Snapper (Red, Gray, Malabar, etc.)
Date Published: 03/13/2009

Notes: 4/1/2005 16 A - - 45 Tuna (Albacore, Yellowfin, Bluefin, Skipjack, Etc.)
Date Published: 03/13/2009

Notes: 4/1/2005 16 A - - 51 Mahi Mahi
Date Published: 03/13/2009

Notes: 4/1/2005 16 A - - 69 Escolar
Date Published: 03/13/2009

Notes: 4/1/2005 16 A - - 70 Shad, Alewife
Date Published: 03/13/2009

Notes: 4/1/2005 16 A - - 71 Jack
Date Published: 03/13/2009

Notes: 4/1/2005 16 A - - 73 Mackerel (all except Scomberomorus sp, eg Spanish or King see '22')
Date Published: 03/13/2009

Notes: 4/1/2005 16 A - - 76 Saury
Date Published: 03/13/2009

Notes: 4/1/2005 16 A - - 78 Wahoo
Date Published: 03/13/2009

Notes: 4/1/2005 16 A - - 79 Yellowtail, Amberjack
Date Published: 03/13/2009

Notes: 4/1/2005 Mucuripe Pesca Ltda Date Published : 03/13/2009 Rua Chile, No. 66, , Bairro Ribeira
, Natal,
RN BRAZIL 16 A - - 42 Swordfish
Date Published: 03/13/2009

Notes: 10/29/2003 16 A - - 51 Mahi Mahi
Date Published: 03/13/2009

Notes: 10/29/2003 16 A - - 54 Marlin
Date Published: 03/13/2009

Notes: 10/29/2003 16 A - - 69 Escolar
Date Published: 03/13/2009

Notes: 10/29/2003 16 J - - 05 Shrimp & Prawns
Date Published: 03/13/2009

Notes: 10/29/2003 Taiyo Industria De Pesca Date Published : 03/13/2009 Rua Octavio Correa 119
, Santos,
Sao Paulo BRAZIL 16 A - - 45 Tuna (Albacore, Yellowfin, Bluefin, Skipjack, Etc.)
Date Published: 03/13/2009

Notes: 8/8/2003 16 A - - 51 Mahi Mahi
Date Published: 03/13/2009

Notes: 8/8/2003 16 A - - 54 Marlin
Date Published: 03/13/2009

Notes: 8/8/2003 16 A - - 69 Escolar
Date Published: 03/13/2009

Notes: 8/8/2003

BURMA (MYANMAR)

MAY YU MARINE PRODUCTS CO. LTD Date Published : 05/16/2017 NO.525, MAY YU STREET , INDUSTRIAL ZONE 1
, South Dagon T/s,
Yangon BURMA (MYANMAR) 16 A - - -- Fish
Date Published: 05/16/2017

Desc: Fresh Water Fish Notes: Problem(s);HACCP violations

CANADA

Cap-Pele Herring Export Inc. Date Published : 09/16/2009 2661m Ch Acadie
, Cap-Pele,
New Brunswick CANADA 16 S - P 21 Herring, Cold Smoked, Fish, Cultured/Cured
Date Published: 09/01/2021

Desc: Smoked herring Notes: 2/11/2009 Seven Seas Seafood Fish Co., Ltd. Date Published : 10/14/2012 12411 Vulcan Way
, Richmond,
British Columbia CANADA 16 S - - -- Fish, Cold Smoked (protein is not coagulated)
Date Published: 07/19/2013

Desc: All Cold Smoked Fishery/Seafood Products Notes: Exception for all other seafood products which are not subject to
DWPE

CHILE

Comercial Comtesa S.A. Date Published : 03/18/2014 Lautaro Navarro 1398
, Punta Arenas,
CHILE 16 J - - 01 Crab
Date Published: 03/18/2014

Desc: Crab (cooked then frozen/vacuum packed) Empacadora Lota Seafoods S.A. Date Published : 02/27/2026 Parque Industrial, Lote 13 Y 14
, Lota,
Region del Bio-Bio CHILE 16 A - - -- Fish
Date Published: 02/27/2026

Desc: All histamine forming species seafood; specifically frozen; raw; vacuum packed/ROP; wild caught Swordfish head gut tail (HGT); and loin Notes: FDA inspection of this food manufacturing facility found serious deviations of the seafood HACCP regulations (21 CFR Part 123). Based on FDA?s inspectional findings and review of the firm?s response, the FDA determined that the firm?s histamine forming species such as frozen, raw, vacuum-packed, wild caught Swordfish head-gut-tail (HGT) and loin seafood products processed in the facility appear to be adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act. Identified violations include: 21 CFR 123.6(c)(1), failure to identify hazards likely to occur; 21 CFR 123.6(c)(3), inadequate critical limit; and 21 CFR 123.6(c)(4), inadequate monitoring procedures. Pesquera Alvarez y Alvarez Ltda Date Published : 08/05/2014 Huerto 68A Lote 2 , DUODECIMA REGION
, Puerto Natales,
MAGALLANES ANTARTICA CHILE 16 J V - 01 Crab, Vacuum or Modified Atmosphere Packaging
Date Published: 08/05/2014

Desc: Vacuum packed frozen cooked king crabmeat Notes: Problem(s):
Violative inspection conducted at the foreign facility in May 2013.
WL issued December 2013
Firm's response received in February 2014 failed to provide adequate corrections

CHINA

Inter-Foods (Dongshan) Co., Ltd. Date Published : 06/19/2013 Economic And , East West Road
, Dongshan,
Fujian CHINA 16 A - - 33 Sardines (Brisling, Sprats, Pilchards, Etc.)
Date Published: 06/19/2013

Desc: Sardines Products 16 A - - 59 Scad
Date Published: 06/19/2013

Desc: Japanese Scad 16 A - - 73 Mackerel (all except Scomberomorus sp, eg Spanish or King see '22')
Date Published: 06/19/2013

Desc: Mackerel Weifang Green Life Foods Co.,Ltd Date Published : 10/15/2025 No. 2 Zhenxing Rd , Zhugouzhen Gaomi
, Weifang,
Shandong CHINA 16 O - - 03 Oysters, Hot Smoked, Shellfish
Date Published: 10/15/2025

Desc: Canned smoked oysters Notes: Based on FDA?s inspectional findings, the firm?s canned smoked oyster products appear to be adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. ? 342(a)(4)]. Specific violations include: The firm?s HACCP plan failing to list the food safety hazards [123.6(c)(1)]; The HACCP plan includes corrective actions that are not adequate [21 CFR 123.7(b)]; Failure to monitor sanitation conditions and practices [21 CFR 123.11(b)]; and Failure to control PFSA as hazard likely to occur [123.6(a) and (c)(1)].

COSTA RICA

Alimentos Prosalud SA Date Published : 11/01/2013 1KM Al Oeste De La Interseccion Sobre La Carretera Costanera
, Barranca,
Puntarenas COSTA RICA 16 A - - 33 Sardines (Brisling, Sprats, Pilchards, Etc.)
Date Published: 11/01/2013

Desc: All Sardine Products

CROATIA

Ostrea d.o.o. Date Published : 05/22/2015 Ulica Hrvatske Vlade 1
, Stankovci,
Zadarska CROATIA 16 A - - 22 Mackerel (only Scomberomorus spp eg. Spanish or King)
Date Published: 05/22/2015

Desc: Mackerel; Spanish or King 16 A - - 33 Sardines (Brisling, Sprats, Pilchards, Etc.)
Date Published: 05/22/2015

Desc: Sardines 16 A - - 45 Tuna (Albacore, Yellowfin, Bluefin, Skipjack, Etc.)
Date Published: 05/22/2015

Desc: Tuna 16 A - - 73 Mackerel (all except Scomberomorus sp, eg Spanish or King see '22')
Date Published: 05/22/2015

Desc: Mackerel (all except Spanish or king)

DENMARK

Agustson A/S Date Published : 11/25/2024 Englandsvej 11
, Vejle,
Syddanmark DENMARK 16 I V - 44 Trout (Rainbow, Brook, Brown, Char, Steelhead, etc.), Hot Smoked, Fish, Vacuum or Modified Atmosphere Packaging
Date Published: 11/25/2024

Desc: Frozen Smoked Trout Fillets Notes: HACCP violations, 3/2024 16 S V - 44 Trout (Rainbow, Brook, Brown, Char, Steelhead, etc.), Cold Smoked, Fish, Vacuum or Modified Atmosphere Packaging
Date Published: 11/25/2024

Desc: Frozen Smoked Trout Fillets Notes: HACCP violations, 3/2024

DOMINICAN REPUBLIC (THE)

Chean Industries Dominicana S.R.L. Date Published : 01/29/2024 Calle 21 No. 3, De La Urbanizacion Los Girasoles Del Este
, Santiago,
DOMINICAN REPUBLIC (THE) 16 M - - 10 Sea Cucumber, Other Aquatic Species
Date Published: 01/29/2024

Desc: Sea Cucumber Notes: HACCP violations, 7/10/2023 16 N - - 10 Sea Cucumber, Breaded, Other Aquatic Species
Date Published: 01/29/2024

Desc: Sea Cucumber Notes: HACCP violations, 7/10/2023

ECUADOR

Clarich S.A. Date Published : 03/13/2009 Cdla. Prosperina, Callejon 1era 723 Y
, Guayaquil,
Guayas ECUADOR 16 A E E 33 Sardines (Brisling, Sprats, Pilchards, Etc.), Metal, Commercially Sterile
Date Published: 09/01/2021

Desc: Canned sardines Notes: 2/20/2004 EMPREDE S.A. Date Published : 02/17/2012 G. Cubillo 1212 y E. Romero
, Tarqui,
Guayas ECUADOR 16 A - - 01 Anchovy
Date Published: 07/15/2013

Desc: Histamine forming fish species 16 A - - 05 Blue Fish
Date Published: 07/15/2013

Desc: Histamine forming fish species 16 A - - 07 Bonito
Date Published: 07/15/2013

Desc: Histamine forming fish species 16 A - - 21 Herring
Date Published: 07/15/2013

Desc: Histamine forming fish species 16 A - - 22 Mackerel (only Scomberomorus spp eg. Spanish or King)
Date Published: 07/15/2013

Desc: Histamine forming fish species 16 A - - 33 Sardines (Brisling, Sprats, Pilchards, Etc.)
Date Published: 07/15/2013

Desc: Histamine forming fish species 16 A - - 37 Snapper (Red, Gray, Malabar, etc.)
Date Published: 07/15/2013

Desc: Histamine forming fish species 16 A - - 45 Tuna (Albacore, Yellowfin, Bluefin, Skipjack, Etc.)
Date Published: 07/15/2013

Desc: Histamine forming fish species 16 A - - 51 Mahi Mahi
Date Published: 07/15/2013

Desc: Histamine forming fish species 16 A - - 54 Marlin
Date Published: 07/15/2013

Desc: Histamine forming fish species 16 A - - 59 Scad
Date Published: 07/15/2013

Desc: Histamine forming fish species 16 A - - 69 Escolar
Date Published: 07/15/2013

Desc: Histamine forming fish species 16 A - - 69 Escolar
Date Published: 02/17/2012

Desc: Frozen Raw Escolar 16 A - - 70 Shad, Alewife
Date Published: 07/15/2013

Desc: Histamine forming fish species 16 A - - 71 Jack
Date Published: 07/15/2013

Desc: Histamine forming fish species 16 A - - 76 Saury
Date Published: 07/15/2013

Desc: Histamine forming fish species 16 A - - 78 Wahoo
Date Published: 07/15/2013

Desc: Histamine forming fish species 16 A - - 79 Yellowtail, Amberjack
Date Published: 07/15/2013

Desc: Histamine forming fish species 16 A - - 86 Sculpin
Date Published: 07/15/2013

Desc: Histamine forming fish species 16 A - - 87 Patagonian Toothfish, Chilean Seabass
Date Published: 07/15/2013

Desc: Histamine forming fish species 16 A - - 88 Gemfish
Date Published: 07/15/2013

Desc: Histamine forming fish species 16 A - - 89 Kahawa
Date Published: 07/15/2013

Desc: Histamine forming fish species 16 A - - 90 Sailfish
Date Published: 07/15/2013

Desc: Histamine forming fish species 16 A - - 91 Spearfish
Date Published: 07/15/2013

Desc: Histamine forming fish species 16 A - - 92 Trevally
Date Published: 07/15/2013

Desc: Histamine forming fish species ESCUALEM S.A. Date Published : 03/13/2009 Km 10.5 Via a Daule , Lotizacion Los Vergeles Mz 265 S/N
, Guayaquil,
Guayas ECUADOR 16 J - N 01 Crab, Heat Treated
Date Published: 03/13/2009

Notes: Cooked stone crab

8/2/2007 Empacadora Bilbo S.A. DBA Bilbosa Date Published : 07/02/2024 Ciudadela Monterrey , Carretera Manta - Montecristi Km 6. 5
, Montecristi,
Manabi ECUADOR 16 A V - -- Fish, Vacuum or Modified Atmosphere Packaging
Date Published: 07/02/2024

Desc: frozen vacuum packaged fish Notes: HACCP violations, 7/28/2023 16 X V - -- Aquaculture Harvested Fishery/Seafood Products, Vacuum or Modified Atmosphere Packaging
Date Published: 07/02/2024

Desc: frozen vacuum packaged fish Notes: HACCP violations, 7/28/2023 Galatuna S.A. Date Published : 09/18/2013 Via Al Embarcadero
, Isla Isabela, Galapagos,
ECUADOR 16 A - - 45 Tuna (Albacore, Yellowfin, Bluefin, Skipjack, Etc.)
Date Published: 09/18/2013

Desc: Tuna 16 A - - 51 Mahi Mahi
Date Published: 09/18/2013

Desc: Mahi Mahi 16 A - - 69 Escolar
Date Published: 09/18/2013

Desc: Escolar 16 A - - 78 Wahoo
Date Published: 09/18/2013

Desc: Wahoo MIYAQUIL SA Date Published : 09/13/2019 Venezuela 4507 y 16
, Guayaquil,
Guayas ECUADOR 16 E - - 02 Clams
Date Published: 09/13/2019

Desc: Frozen Pre-Cooked Clams Notes: An Establishment Inspection revealed the firm to not be operating in compliance with seafood HACCP regulations. Peslasa S.A. Date Published : 01/06/2012 Robles 401 y Estrada Coello
, Guayaquil,
Guayas ECUADOR 16 A - - -- Fish
Date Published: 01/06/2012

Desc: Whole Histamine Forming Fish Star Company S.A. Date Published : 11/20/2014 Avenida Juan Tanca Marengo KM 6.5 , y Gustavo Dominquez
, Guayaquil,
Guayas ECUADOR 16 J - - 05 Shrimp & Prawns
Date Published: 11/20/2014

Desc: Shrimp Notes: Problem: Firm ruled not in compliance with seafood HACCP as result of violative
inspection on 6/2014.Firm was issued a warning letter on September 24; 2014; no
response. 16 X - - 21 Shrimp and prawns, Aquaculture Harvested Fishery/Seafood Products
Date Published: 11/20/2014

Desc: Shrimp Notes: Problem: Firm ruled not in compliance with seafood HACCP as result of violative
inspection on 6/2014. Firm was issued a warning letter on September 24; 2014; no
response.

EL SALVADOR

Carlos Eusebio Moran Urbina Date Published : 03/13/2009 Col.Lorena, Calle Cuscatlan No 7
, San Ramon,
San Salvador EL SALVADOR 16 - - - -- Fishery/Seafood Products
Date Published: 03/13/2009

Desc: all seafood products Notes: 2/9/2004 E. I. Prosal S.A. de C.V. Date Published : 10/01/2013 Col. Maraly, Pje. San Mauricio , Blvd. del Ejercito Nacional Km. 4. 5
, Soyapango,
San Salvador EL SALVADOR 16 A - - 22 Mackerel (only Scomberomorus spp eg. Spanish or King)
Date Published: 10/01/2013

Desc: Mackerel 16 A - - 73 Mackerel (all except Scomberomorus sp, eg Spanish or King see '22')
Date Published: 10/01/2013

Desc: Mackerel Exportadora E Importadora De Products Salvadorenos S A De C Date Published : 10/01/2013 Ave Norte 15
, San Salvador,
EL SALVADOR 16 A - - 22 Mackerel (only Scomberomorus spp eg. Spanish or King)
Date Published: 10/01/2013

Desc: Mackerel 16 A - - 73 Mackerel (all except Scomberomorus sp, eg Spanish or King see '22')
Date Published: 10/01/2013

Desc: Mackerel Pesca Mar Azul, S.A. de C.V. Date Published : 02/06/2026 38 North Avenue # 126
, San Salvador,
Cuscatlan EL SALVADOR 16 A - - -- Fish
Date Published: 02/06/2026

Desc: Fresh refrigerated finfish; dried salted finfish (including scombroid species) Productos Mar y Sol S.A. De C.V. Date Published : 09/09/2013 Lotes # 164-166 De La Calle Al Tamarindo , Canton El Jaguey Kilometro 9
, Municipio La Conchagua,
Departamento De La Union EL SALVADOR 16 A - - 51 Mahi Mahi
Date Published: 09/09/2013

Desc: Mahi & Mahi (Fresh & Frozen) 16 A - - 55 Corvina
Date Published: 09/09/2013

Desc: Dried Salted Corvina 16 J - - 05 Shrimp & Prawns
Date Published: 09/09/2013

Desc: Dried Salted Shrimp 16 X - - 21 Shrimp and prawns, Aquaculture Harvested Fishery/Seafood Products
Date Published: 09/09/2013

Desc: Dried Salted Shrimp San Marino S.A. de C.V. Date Published : 03/13/2009 Carretera el Litoral, Kilometro #111.5 O , Canton La Nueva
, Sonsonate,
EL SALVADOR 16 A - - 45 Tuna (Albacore, Yellowfin, Bluefin, Skipjack, Etc.)
Date Published: 11/19/2009

Desc: Fresh and frozen tuna Notes: 1/16/2004 16 J - - 05 Shrimp & Prawns
Date Published: 03/13/2009

Notes: Raw shrimp

1/16/2004 16 X - - 21 Shrimp and prawns, Aquaculture Harvested Fishery/Seafood Products
Date Published: 03/13/2009

Notes: Raw shrimp

1/16/2004

ESTONIA

AS Spratifil Date Published : 03/13/2009 Lesta 14
, Tallinn,
Harju ESTONIA 16 A - - 21 Herring
Date Published: 03/13/2009

Notes: 6/25/2004 16 A - - 33 Sardines (Brisling, Sprats, Pilchards, Etc.)
Date Published: 03/13/2009

Notes: 6/25/2004 16 I - - 21 Herring, Hot Smoked, Fish
Date Published: 03/13/2009

Notes: 6/25/2004 16 I - - 33 Sardines (Brisling, Sprats, Pilchards, etc.), Hot Smoked, Fish
Date Published: 03/13/2009

Notes: 6/25/2004 16 S - - 21 Herring, Cold Smoked, Fish
Date Published: 03/13/2009

Notes: 6/25/2004 16 S - - 33 Sardines (Brisling, Sprats, Pilchards, etc.), Cold Smoked, Fish
Date Published: 03/13/2009

Notes: 6/25/2004 Viru Kalatoostuse OU Date Published : 03/13/2009 Joe 12 Street
, Toila Alevik,
Ida-Viru maakond ESTONIA 16 A E E 33 Sardines (Brisling, Sprats, Pilchards, Etc.), Metal, Commercially Sterile
Date Published: 09/17/2021

Desc: Canned Sprats Notes: 4/26/2004

FIJI

CAKAUDROVE FISH Date Published : 03/13/2009 11 Bureta Street
, Suva,
Fj-Nota FIJI 16 A - - 22 Mackerel (only Scomberomorus spp eg. Spanish or King)
Date Published: 03/13/2009

Notes: 4/19/2007 16 A - - -- Fish
Date Published: 11/19/2009

Desc: All histamine forming species Notes: 4/19/2007 Star Dragon Trading Date Published : 09/16/2009 79 Ackland Street
, Suvavou,
FIJI 16 M - - 10 Sea Cucumber, Other Aquatic Species
Date Published: 09/16/2009

Notes: Dried Sea Cucumbers

6/15/2009 16 U - - 10 Sea Cucumber, Hot Smoked, Other Aquatic Species
Date Published: 09/16/2009

Notes: Dried Sea Cucumbers

6/15/2009 Star Dragon Trading Date Published : 09/16/2009 79 Ackland Street
, Suvavou,
FIJI 16 M - - 10 Sea Cucumber, Other Aquatic Species
Date Published: 10/01/2009

Desc: Dried Sea Cucumbers 16 M - - 10 Sea Cucumber, Other Aquatic Species
Date Published: 09/16/2009

Notes: Dried Sea Cucumbers 16 U - - 10 Sea Cucumber, Hot Smoked, Other Aquatic Species
Date Published: 09/16/2009

Notes: Dried Sea Cucumbers

FRANCE

Demarne Date Published : 11/06/2013 5 Rue Des Claires
, Rungis,
None of the above FRANCE 16 A - - 01 Anchovy
Date Published: 11/06/2013

Desc: Eviscerated 16 A - - 21 Herring
Date Published: 11/06/2013

Desc: Smoked Herring Filet in sous vide 16 A - - 33 Sardines (Brisling, Sprats, Pilchards, Etc.)
Date Published: 11/06/2013

Desc: Raw Sardines 16 I - - 21 Herring, Hot Smoked, Fish
Date Published: 11/06/2013

Desc: Smoked Herring Filet in sous vide 16 S - - 21 Herring, Cold Smoked, Fish
Date Published: 11/06/2013

Desc: Smoked Herring Filet in sous vide Kaviari Date Published : 08/23/2013 13 Rue De L Arsenal
, Paris,
Paris FRANCE 16 Y - - 01 Caviar, Fishery Products, n.e.c.
Date Published: 08/23/2013

Desc: Caviar L'Esturgeonniere Date Published : 01/20/2026 10 Rue De Balanos
, Le Teich,
Gironde FRANCE 16 X - - 04 Sturgeon, Aquaculture Harvested Fishery/Seafood Products
Date Published: 01/20/2026

Desc: Vacuum-Packed; Ready-to-Eat (RTE) Aquaculture Sturgeon Caviar Notes: FDA inspection conducted at this food manufacturing facility found serious deviations of the Seafood HACCP regulations (21 CFR Part 123). Based on FDA?s inspectional findings and review of firm?s response, the firm?s Sturgeon Caviar products appear adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act), in that they were prepared, packed or held under insanitary conditions whereby they may have been contaminated with filth, or whereby they may have been rendered injurious to health. Specific violations include: 21 CFR 123.6(a) and (c)(2), failure to conduct a hazard analysis to determine whether there are food safety hazards that are reasonably likely to occur and have a HACCP plan that, at a minimum, lists the critical control points. 16 Y - - 01 Caviar, Fishery Products, n.e.c.
Date Published: 01/20/2026

Desc: Vacuum-Packed; Ready-to-Eat (RTE) Aquaculture Sturgeon Caviar Notes: FDA inspection conducted at this food manufacturing facility found serious deviations of the Seafood HACCP regulations (21 CFR Part 123). Based on FDA?s inspectional findings and review of firm?s response, the firm?s Sturgeon Caviar products appear adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act), in that they were prepared, packed or held under insanitary conditions whereby they may have been contaminated with filth, or whereby they may have been rendered injurious to health. Specific violations include: 21 CFR 123.6(a) and (c)(2), failure to conduct a hazard analysis to determine whether there are food safety hazards that are reasonably likely to occur and have a HACCP plan that, at a minimum, lists the critical control points. Reunipeche Date Published : 05/21/2025 9 Rue D'Armagnac
, Le Port,
La Reunion FRANCE 16 A - C -- Fish, Raw, Fresh, Refrigerated
Date Published: 05/21/2025

Desc: Whole Fresh Fish Notes: Problem(s): HACCP violations; 7/2024

Firm?s HACCP plan has an inadequate monitoring procedure for testing histamine level at the CCP1 critical control point to control scombrotoxin (histamine) formation. The HACCP plan corrective action plans at the CCP1, CCP2, and CCP4 critical control points are inappropriate to control scombrotoxin (histamine) formation. Additionally, the critical limit at CCP3 clearly define the maximum temperature value, rather than referencing a tolerance. The monitoring procedure listed on the HACCP plan for the CCP3 critical control point should include measuring the internal temperature of a representative number of the largest fish in each lot or measure a minimum of 12 fish AND visually determine the date and time of off-loading. Monitoring records for CCP 3 should also include whether the fish were accepted or rejected based on temperature. Reunipeche SAS Date Published : 05/21/2025 Batiment 20 , Le Port
, La Reunion,
Le Port FRANCE 16 A - C -- Fish, Raw, Fresh, Refrigerated
Date Published: 05/21/2025

Desc: Whole Fresh Fish Notes: Problem(s); HACCP violations; 7/2024

Firm?s HACCP plan has an inadequate monitoring procedure for testing histamine level at the CCP1 critical control point to control scombrotoxin (histamine) formation. The HACCP plan corrective action plans at the CCP1, CCP2, and CCP4 critical control points are inappropriate to control scombrotoxin (histamine) formation. Additionally, the critical limit at CCP3 clearly define the maximum temperature value, rather than referencing a tolerance. The monitoring procedure listed on the HACCP plan for the CCP3 critical control point should include measuring the internal temperature of a representative number of the largest fish in each lot or measure a minimum of 12 fish AND visually determine the date and time of off-loading. Monitoring records for CCP 3 should also include whether the fish were accepted or rejected based on temperature. SAS ROQUE Date Published : 06/05/2020 5 Rue Du Grenache , Bp 39
, Collioure,
Pyrenees Orientales FRANCE 16 A - - 01 Anchovy
Date Published: 06/05/2020

Desc: ready-to-eat anchovy products Notes: HACCP Violations noted, February, 2020

GREECE

Karagounis Bros. S.A. Date Published : 12/11/2025 2nd Industrial Zone of Volos
, Velestino,
Larisas GREECE 16 A - - -- Fish
Date Published: 12/11/2025

Desc: All smoked fishery products Notes: HACCP violations 16 I - - -- Fish, Hot Smoked (protein is coagulated throughout
Date Published: 12/11/2025

Desc: All smoked fishery products Notes: HACCP violations 16 M - - -- Other Aquatic Species
Date Published: 12/11/2025

Desc: All smoked fishery products Notes: HACCP violations 16 S - - -- Fish, Cold Smoked (protein is not coagulated)
Date Published: 12/11/2025

Desc: All smoked fishery products Notes: HACCP violations 16 U - - -- Other Aquatic Species, Hot Smoked (coagulated)
Date Published: 12/11/2025

Desc: All smoked fishery products Notes: HACCP violations 16 V - - -- Other Aquatic Species, Cold Smoked (not coagulated
Date Published: 12/11/2025

Desc: All smoked fishery products Notes: HACCP violations 16 X - - -- Aquaculture Harvested Fishery/Seafood Products
Date Published: 12/11/2025

Desc: All smoked fishery products Notes: HACCP violations 16 Y - - -- Fishery Prod,n.e.c.
Date Published: 12/11/2025

Desc: All smoked fishery products Notes: HACCP violations Pavlos Trifonidis S.A Date Published : 01/21/2020 Industrial Zone of Kavala
, Chrysoupoli,
GREECE 16 A - - 01 Anchovy
Date Published: 01/21/2020

Desc: Anchovy Canned and Salted Notes: HACCP Violations noted, July 2019 16 A - - 45 Tuna (Albacore, Yellowfin, Bluefin, Skipjack, Etc.)
Date Published: 01/21/2020

Desc: Tuna in Oil "Lakerda" Thunnus Alalunga Notes: HACCP Violations noted, July 2019

GUYANA

Fanta Seafoods Date Published : 01/29/2024 Coldingen Industrial Estate , Lot 3; East Coast Demerara
, Georgetown,
GUYANA 16 A - - 22 Mackerel (only Scomberomorus spp eg. Spanish or King)
Date Published: 01/29/2024

Desc: Mackerel; Scomberomorus spp Notes: HACCP violations, 9/28/2023 16 A - - 99 Fish, N.E.C.
Date Published: 01/29/2024

Desc: Shrimp; Nematopalaemon schmitti Notes: HACCP violations, 9/28/2023 16 J - - 05 Shrimp & Prawns
Date Published: 01/29/2024

Desc: Shrimp; Nematopalaemon schmitti Notes: HACCP violations, 9/28/2023 16 X - - 21 Shrimp and prawns, Aquaculture Harvested Fishery/Seafood Products
Date Published: 01/29/2024

Desc: Shrimp; Nematopalaemon schmitti Notes: HACCP violations, 9/28/2023

HONDURAS

Promar Seafood S. de R.L. Date Published : 04/19/2022 Contiguo A La Naval , Carretera Muelle De Cabotaje
, La Ceiba,
Atlantida HONDURAS 16 M - - 10 Sea Cucumber, Other Aquatic Species
Date Published: 04/19/2022

Desc: Sea Cucumber Notes: HACCP Violations noted; March 2022 16 U - - 10 Sea Cucumber, Hot Smoked, Other Aquatic Species
Date Published: 04/19/2022

Desc: Sea Cucumber Notes: HACCP Violations noted; March 2022 16 V - - 10 Sea Cucumber, Cold Smoked, Other Aquatic Species
Date Published: 04/19/2022

Desc: Sea Cucumber Notes: HACCP Violations noted; March 2022

HONG KONG SAR

Hang Hing Marine Products Company Date Published : 07/15/2013 Shop No. 8, G/F , Sunglow Building 11-15; Kennedy Town Praya
, Hong Kong,
Hong Kong Island HONG KONG SAR 16 A - H -- Fish, Ntrl/Artfcl Dried
Date Published: 07/15/2013

Desc: Dried Fish Hang Tai Marine Products Co. Date Published : 05/30/2013 Shop 2, G/Fl. , 155 Connaught Road West
, Hong Kong,
HK-NA HONG KONG SAR 16 A - H -- Fish, Ntrl/Artfcl Dried
Date Published: 05/30/2013

Desc: Dried Fish

ICELAND

Klausturbleikja ehf. Date Published : 01/21/2020 Klausturvegi 5
, Kirkjubajarklaustri,
South ICELAND 16 A - - 44 Trout (Rainbow, Brook, Brown, Char, Steelhead, Etc.)
Date Published: 01/21/2020

Desc: Cold Smoked Arctic Char Vac-Pac Salvelinus alpinus Notes: HACCP Violations noted, September 2019 16 S - - 44 Trout (Rainbow, Brook, Brown, Char, Steelhead, etc.), Cold Smoked, Fish
Date Published: 01/21/2020

Desc: Cold Smoked Arctic Char Vac-Pac Salvelinus alpinus Notes: HACCP Violations noted, September 2019 16 X - - 05 Trout, all, Aquaculture Harvested Fishery/Seafood Products
Date Published: 01/21/2020

Desc: Cold Smoked Arctic Char Vac-Pac Salvelinus alpinus Notes: HACCP Violations noted, September 2019

INDIA

ABAD EXIM PVT. LTD. Date Published : 03/13/2009 Plot No:32&33 , Cochin Special Economic Zone, Kakkanad
, Kochi,
Kerala INDIA 16 W - - 22 Seafood salad (shrimp, crab, etc.), Mixed Fishery/Seafood Products
Date Published: 03/13/2009

Desc: frozen seafood mix Notes: 8/28/2001 16 W - - 99 Mixed Fishery/Seafood Products, N.E.C.
Date Published: 03/13/2009

Desc: frozen seafood mix Notes: 8/28/2001 16 Y - - 99 Fishery Products, N.E.C.
Date Published: 03/13/2009

Desc: frozen seafood mix Notes: 8/28/2001 Britto Sea Foods Exports Pvt. Ltd. Date Published : 04/29/2014 C-1 Part SIPCOT Industrial Complex
, Tuticorin,
Tamil Nadu INDIA 16 A - - 45 Tuna (Albacore, Yellowfin, Bluefin, Skipjack, Etc.)
Date Published: 04/29/2014

Desc: Yellowfin Tuna products Notes: Britto Sea Foods Exports Pvt. Ltd. Date Published : 04/29/2014 C-1 Part SIPCOT Industrial Complex
, Tuticorin,
Tamil Nadu INDIA 16 A - - 45 Tuna (Albacore, Yellowfin, Bluefin, Skipjack, Etc.)
Date Published: 04/29/2014

Desc: Yellowfin Tuna products Keshodwala Foods (Unit 1) Date Published : 09/15/2015 Plot No 305 Gidc Estate
, Veraval,
Gujarat INDIA 16 A - - 22 Mackerel (only Scomberomorus spp eg. Spanish or King)
Date Published: 09/15/2015

Desc: Mackerel; Spanish 16 A - - 45 Tuna (Albacore, Yellowfin, Bluefin, Skipjack, Etc.)
Date Published: 01/03/2019

Desc: Yellowfin Tuna Notes: Violations of Seafood HACCP regulation; 21 CFR 123. 16 A - - 51 Mahi Mahi
Date Published: 09/15/2015

Desc: Mahi Mahi 16 A - - 73 Mackerel (all except Scomberomorus sp, eg Spanish or King see '22')
Date Published: 09/15/2015

Desc: Mackerel; Indian Keshodwala Foods (Unit 2) Date Published : 12/02/2016 Plot No 306 Gidc Estate
, Veraval,
Gujarat INDIA 16 A - - 22 Mackerel (only Scomberomorus spp eg. Spanish or King)
Date Published: 02/21/2019

Desc: King Mackerel Notes: Problem(s); HACCP violations 16 A - - 22 Mackerel (only Scomberomorus spp eg. Spanish or King)
Date Published: 02/21/2019

Desc: Spanish Mackerel Notes: Problem(s); HACCP violations 16 A - - 45 Tuna (Albacore, Yellowfin, Bluefin, Skipjack, Etc.)
Date Published: 12/02/2016

Desc: Tuna Notes: Problem(s):
HACCP violations 16 A - - 51 Mahi Mahi
Date Published: 12/02/2016

Desc: Mahi-Mahi Notes: Problem(s): HACCP violations 16 A - - 73 Mackerel (all except Scomberomorus sp, eg Spanish or King see '22')
Date Published: 12/02/2016

Desc: Mackerel (Indian and Horse) Notes: Problem(s): HACCP violations MOON FISHERY INDIA PVT LTD Date Published : 08/01/2012 G255 Cochin
, Ernakulam,
Kerala INDIA 16 A - - 45 Tuna (Albacore, Yellowfin, Bluefin, Skipjack, Etc.)
Date Published: 08/01/2012

Desc: Tuna Notes: Note; Office location for the Moon Fishery India Pvt Ltd Factory Moon Fishery (India) Pvt Ltd Date Published : 08/01/2012 11/722/D, Chemical Industrial Estate , Aroor, Alleppey
, Kerala,
INDIA 16 A - - 45 Tuna (Albacore, Yellowfin, Bluefin, Skipjack, Etc.)
Date Published: 08/01/2012

Desc: Tuna Notes: Note; Factory location for the Moon Fishery India Pvt. Ltd office. Phillips Foods India Pvt. Ltd Date Published : 03/13/2009 C-75/76 Sipcot Industrial Complex , 1011 Supalai Grand Tower, Rama III Road
, Tuticorin,
Tamil Nadu INDIA 16 A V - 45 Tuna (Albacore, Yellowfin, Bluefin, Skipjack, Etc.), Vacuum or Modified Atmosphere Packaging
Date Published: 03/13/2009

Notes: frozen tuna portions

5/22/2006 Sea Fresh Exports Limited Date Published : 03/13/2009 P.O. Box No. 9
, Aroor,
Kerala INDIA 16 A - D 01 Anchovy, Raw - Fresh, Frozen, Natural State
Date Published: 09/17/2021

Desc: IQF Anchovies Notes: 11/26/2001 16 A - D 22 Mackerel (only Scomberomorus spp eg. Spanish or King), Raw - Fresh, Frozen, Natural State
Date Published: 09/17/2021

Desc: IQF Mackerel Notes: 11/26/2001 16 A - D 73 Mackerel (all except Scomberomorus sp, eg Spanish or King see '22'), Raw - Fresh, Frozen, Natural State
Date Published: 09/17/2021

Desc: IQF Mackerel Notes: 11/26/2001 16 A - D 99 Fish, N.E.C., Raw - Fresh, Frozen, Natural State
Date Published: 09/17/2021

Desc: IQF Seerfish Notes: 11/26/2001

INDONESIA

PT Anugerah Lestari Abadi Date Published : 03/08/2018 Jl raya Narogong Km 12 Pangkalan II No 4
, Bekasi,
Jabotabek INDONESIA 16 A - - 45 Tuna (Albacore, Yellowfin, Bluefin, Skipjack, Etc.)
Date Published: 03/08/2018

Desc: Tuna Notes: Problem(s);
HACCP Violations PT Sekar Subur Abadi Date Published : 03/08/2018 Jln. Cilincing Raya 30A
, Jakarta,
Jabotabek INDONESIA 16 A - - 45 Tuna (Albacore, Yellowfin, Bluefin, Skipjack, Etc.)
Date Published: 03/08/2018

Desc: Tuna Notes: HACCP violations PT Shimasse Prata Citra Date Published : 04/05/2018 Jl raya Narogong Pangkalan III
, Bekasi,
Jawa Barat INDONESIA 16 A - - 45 Tuna (Albacore, Yellowfin, Bluefin, Skipjack, Etc.)
Date Published: 04/05/2018

Desc: Tuna Notes: Problem(s);
HACCP Violations PT Tritunggal Lintas Benua Date Published : 12/02/2016 Jln. Muara Karang S No. 50
, Jakarta,
Jabotabek INDONESIA 16 A - - 45 Tuna (Albacore, Yellowfin, Bluefin, Skipjack, Etc.)
Date Published: 12/02/2016

Desc: Tuna Notes: Problem(s);
HACCP violations PT. Anugrah Laut Indonesia Date Published : 05/23/2025 Jl. Rembang Tuban Km 40, Desa Bancar, Kecamatan Bancar
, Tuban,
Jawa Timur INDONESIA 16 A V - 45 Tuna (Albacore, Yellowfin, Bluefin, Skipjack, Etc.), Vacuum or Modified Atmosphere Packaging
Date Published: 05/23/2025

Desc: Vacuum-packed Tuna Notes: Problem(s); HACCP violations; 12/2024 PT. GALAXY NUSA DUA Date Published : 03/20/2018 Jln. Galunggung Raya
, Bekasi,
Jabotabek INDONESIA 16 A - - 45 Tuna (Albacore, Yellowfin, Bluefin, Skipjack, Etc.)
Date Published: 03/20/2018

Desc: Frozen Tuna PT. Galaxi Nusa Dua Date Published : 03/20/2018 Jl. Jatiwaringin Raya No 260-D
, Bekasi,
Jabotabek INDONESIA 16 A - - 45 Tuna (Albacore, Yellowfin, Bluefin, Skipjack, Etc.)
Date Published: 03/20/2018

Desc: Frozen Tuna PT. Nusantara Jaya Abadi Date Published : 04/24/2018 Jln. Gajah Mada 3-5
, Jakarta,
Jabotabek INDONESIA 16 A - - 45 Tuna (Albacore, Yellowfin, Bluefin, Skipjack, Etc.)
Date Published: 04/24/2018

Desc: Tuna Notes: HACCP Violations PT. Winson Prima Sejahtera Date Published : 01/23/2024 Jl. Pulau Solor Street No 11 Kim Ii
, Medan,
Sumatera Utara INDONESIA 16 A - - 45 Tuna (Albacore, Yellowfin, Bluefin, Skipjack, Etc.)
Date Published: 01/23/2024

Desc: Tuna Notes: HACCP violations, April 2023 Pt. Bitung Mina Utama Date Published : 03/29/2012 Jl. Aertembaga 2 Lingkungan 2
, Bitung,
North Sulawesi INDONESIA 16 A V - 45 Tuna (Albacore, Yellowfin, Bluefin, Skipjack, Etc.), Vacuum or Modified Atmosphere Packaging
Date Published: 03/29/2012

Desc: Frozen Vacuum Packed Raw Tuna Pt.Sukse Sejati Date Published : 03/13/2018 Jl Cempaka 9
, Jakarta,
INDONESIA 16 A - - 45 Tuna (Albacore, Yellowfin, Bluefin, Skipjack, Etc.)
Date Published: 03/13/2018

Desc: Tuna Notes: Problem(s);
HACCP Violations;
CFSAN recommends the firm to be added to Import Alert #16-120 after issuing a Warning Letter in January 2018 due to their evaluation of the firms HACCP plan per the Seafood HACCP regulation; 21 CFR 123. The firm has not responded to the Warning Letter. Transbuana international express Date Published : 03/07/2018 Alinda Kencana C3 no. 14
, Bekasi,
Jabotabek INDONESIA 16 A - - 45 Tuna (Albacore, Yellowfin, Bluefin, Skipjack, Etc.)
Date Published: 03/07/2018

Desc: Tuna Notes: HACCP Violations Tritos Sejahtera Date Published : 03/13/2018 Ps Induk Kramat Jati Blok D1 no 015
, Jakarta,
Jakarta Raya INDONESIA 16 A - - 45 Tuna (Albacore, Yellowfin, Bluefin, Skipjack, Etc.)
Date Published: 03/13/2018

Desc: Frozen Tuna pt Mitra T.N. Date Published : 03/08/2018 Jln. Sultan Abdullah 3-9
, Makassar,
Sulawesi Selatan INDONESIA 16 A - - 45 Tuna (Albacore, Yellowfin, Bluefin, Skipjack, Etc.)
Date Published: 03/08/2018

Desc: Tuna

ITALY

DELFINO BATTISTA SRL Date Published : 11/21/2019 Corso Umberto Primo 58
, Cetara,
Salerno ITALY 16 A - - 01 Anchovy
Date Published: 07/20/2021

Desc: Anchovies Sauce Colatura of Cetara Notes: 16 Y - - 09 Fish Sauce, Fishery Products, n.e.c.
Date Published: 07/20/2021

Desc: Anchovies Sauce Colatura of Cetara Notes: DELFINO BATTISTA SRL Date Published : 11/21/2019 Via Gioacchino Rossini N. 1
, Montecorvino Pugliano,
Salerno ITALY 16 A - - 01 Anchovy
Date Published: 07/20/2021

Desc: Anchovies Sauce Colatura of Cetara Notes: 16 Y - - 09 Fish Sauce, Fishery Products, n.e.c.
Date Published: 07/20/2021

Desc: Anchovies Sauce Colatura of Cetara Notes: SOLKY Affumicati e Salati di Fois Fernando Antioco Date Published : 12/13/2010 Via Camillo Benso Conte Di Cavour 164
, Sant'Antioco,
Sud Sardegna ITALY 16 - - - -- Fishery/Seafood Products
Date Published: 12/13/2010

Desc: All Seafood Products

JAPAN

Fukusui Shoji Ltd. Date Published : 03/05/2024 3 Chome 14-1 C , Nagahama; Chuo
, Fukuoka,
Fukuoka JAPAN 16 - - - -- Fishery/Seafood Products
Date Published: 03/05/2024

Desc: All Seafood Notes: HACCP violations; 2/21/2024 HICHIFUKU JYOZO CO.,LTD. Date Published : 05/16/2025 2 Chome 7 , Yamagami-Machi
, Hekinan,
Aichi JAPAN 28 J - - 99 Mixed Spices and Seasoning With Salt, N.E.C.
Date Published: 05/16/2025

Desc: Shiro dashi seafood soup base Notes: HFP recommends the firm to be added to Import Alert #16-120 for significant deviations from the Seafood HACCP regulations 28 K - - 99 Spices and Seasoning, Ground, Cracked, With Salt, N.E.C.
Date Published: 05/16/2025

Desc: Shiro dashi seafood soup base Notes: HFP recommends the firm to be added to Import Alert #16-120 for significant deviations from the Seafood HACCP regulations 37 J - - 05 Soy Sauce
Date Published: 05/16/2025

Desc: Shiro dashi seafood soup base Notes: HFP recommends the firm to be added to Import Alert #16-120 for significant deviations from the Seafood HACCP regulations 38 B - - 99 Concentrated Soup, N.E.C.
Date Published: 05/16/2025

Desc: Shiro dashi seafood soup base Notes: HFP recommends the firm to be added to Import Alert #16-120 for significant deviations from the Seafood HACCP regulations 38 N - - 99 Concentrated Broth, N.E.C.
Date Published: 05/16/2025

Desc: Shiro dashi seafood soup base Notes: HFP recommends the firm to be added to Import Alert #16-120 for significant deviations from the Seafood HACCP regulations Hokuyou Reizou Inc. Date Published : 06/22/2010 12-24 , Showa-Machi
, Sakaiminato,
Tottori JAPAN 16 J - - 01 Crab
Date Published: 06/22/2010

Desc: Frozen Crab Meat 16 J - - 01 Crab
Date Published: 06/22/2010

Desc: Boiled Snow Crab Intersection co., Ltd. Date Published : 12/22/2017 1702-78 , Tsubukuhon-Machi
, Kurume,
Fukuoka JAPAN 16 A - - 05 Blue Fish
Date Published: 12/22/2017

Desc: Bluefish Notes: Problem(s); HACCP Violations 16 A - - 07 Bonito
Date Published: 12/22/2017

Desc: Bonito Notes: Problem(s); HACCP Violations 16 A - - 21 Herring
Date Published: 12/22/2017

Desc: Herring Notes: Problem(s); HACCP Violations 16 A - - 29 Pompano (Permit, Pompanito)
Date Published: 12/22/2017

Desc: Pompano Notes: Problem(s); HACCP Violations 16 A - - 33 Sardines (Brisling, Sprats, Pilchards, Etc.)
Date Published: 12/22/2017

Desc: Sardines Notes: Problem(s); HACCP Violations 16 A - - 45 Tuna (Albacore, Yellowfin, Bluefin, Skipjack, Etc.)
Date Published: 12/22/2017

Desc: Tuna Notes: Problem(s); HACCP Violations 16 A - - 51 Mahi Mahi
Date Published: 12/22/2017

Desc: Mahi Mahi Notes: Problem(s); HACCP Violations 16 A - - 54 Marlin
Date Published: 12/22/2017

Desc: Marlin Notes: Problem(s); HACCP Violations 16 A - - 71 Jack
Date Published: 12/22/2017

Desc: Jack Notes: Problem(s); HACCP Violations 16 A - - 73 Mackerel (all except Scomberomorus sp, eg Spanish or King see '22')
Date Published: 12/22/2017

Desc: Mackerel Notes: Problem(s); HACCP Violations 16 A - - 76 Saury
Date Published: 12/22/2017

Desc: Saury Notes: Problem(s); HACCP Violations 16 A - - 79 Yellowtail, Amberjack
Date Published: 12/22/2017

Desc: Amberjack Notes: Problem(s); HACCP Violations 16 A - - 79 Yellowtail, Amberjack
Date Published: 12/22/2017

Desc: Yellowtail Notes: Problem(s); HACCP Violations 16 A - - 92 Trevally
Date Published: 12/22/2017

Desc: Trevally Notes: Problem(s); HACCP Violations 16 A - - -- Fish
Date Published: 12/22/2017

Desc: All histamine forming fin-fish species; any state Notes: Problem(s);
HACCP Violations 16 X - - -- Aquaculture Harvested Fishery/Seafood Products
Date Published: 12/22/2017

Desc: All histamine forming fin-fish species; any state Notes: Problem(s); HACCP Violations KAKUSHIME MATSUDA SUISAN Date Published : 11/12/2019 247 , Furukawa-Cho
, Hakodate,
Hokkai-do JAPAN 16 A - - 21 Herring
Date Published: 11/12/2019

Desc: Frozen vacuum packaged salted and partially dried herring Notes: An Establishment Inspection revealed the firm to not be operating in compliance with seafood HACCP regulations 21 CFR 123. 16 A - - 21 Herring
Date Published: 02/27/2020

Desc: Non-vacuum packaged partially dried herring products Notes: Firm found to not be operating in compliance with seafood HACCP regulations 21 CFR 123. 16 I - - 21 Herring, Hot Smoked, Fish
Date Published: 11/12/2019

Desc: Frozen vacuum packaged salted and partially dried herring Notes: An Establishment Inspection revealed the firm to not be operating in compliance with seafood HACCP regulations 21 CFR 123. 16 I - - 21 Herring, Hot Smoked, Fish
Date Published: 02/27/2020

Desc: Non-vacuum packaged partially dried herring products Notes: Firm found to not be operating in compliance with seafood HACCP regulations 21 CFR 123. MARUAI CO.,LTD.ATSUTA FACTORY Date Published : 06/10/2011 2 Chome 48-15 1 Ban , Atsuta; Ichiban; Atsuta
, Nagoya,
Aichi JAPAN 16 A - - 07 Bonito
Date Published: 06/10/2011

Desc: Dried Shaved Bonito MARUDAI MINAMI SHOKUHIN Date Published : 01/21/2020 139-30 , Akagawa-Cho
, Hakodate,
Hokkai-do JAPAN 16 A - - 21 Herring
Date Published: 01/21/2020

Desc: Seasoned Herring Vac-Pac RTE Notes: HACCP Violations noted, July 2019 16 M - - 03 Squid, Other Aquatic Species
Date Published: 01/21/2020

Desc: Seasoned Squid w/Spicy Roe Vac-Pac RTE Notes: HACCP Violations noted, July 2019 NARA CO.,LTD. Date Published : 06/05/2024 482-1, NISHIKATA
, Ibusuki,
Kagoshima JAPAN 16 A - - 79 Yellowtail, Amberjack
Date Published: 06/05/2024

Desc: Yellowtail/Amberjack Notes: HACCP violations; 2/7/2023 16 X - - -- Aquaculture Harvested Fishery/Seafood Products
Date Published: 06/05/2024

Desc: Fish; aquaculture; CO processed Notes: HACCP violations; 2/7/2023 NARA CO.,LTD. Date Published : 06/05/2024 482-1, NISHIKATA
, Ibusuki,
Kagoshima JAPAN 16 A - - 79 Yellowtail, Amberjack
Date Published: 06/05/2024

Desc: Yellowtail/Amberjack Notes: HACCP violations; 2/7/2023 16 X - - -- Aquaculture Harvested Fishery/Seafood Products
Date Published: 06/05/2024

Desc: Fish; aquaculture; CO processed Notes: HACCP violations; 2/7/2023 Nakaura Foodstuffs Corp Date Published : 04/23/2010 678 , Nishikawatsu-Cho
, Matsue,
Shimane JAPAN 16 A - - 73 Mackerel (all except Scomberomorus sp, eg Spanish or King see '22')
Date Published: 04/23/2010

Desc: Mackerel 16 A - - 79 Yellowtail, Amberjack
Date Published: 04/23/2010

Desc: Yellowtail Narumiya Co.,Ltd. Date Published : 07/16/2018 Hakata; 4 Chome 1-15; Sumiyoshi; Hakata
, Fukuoka,
Fukuoka JAPAN 16 Y - - 04 Fish Roe, Fishery Products, n.e.c.
Date Published: 07/16/2018

Desc: Fish Roe; Pollack Notes: Problem(s);
HACCP Violations noted; February 2018 Ogura Shokuhin Co Ltd Date Published : 08/21/2024 821-1 Shizuokajapan , Yuiterao; Shimizu
, Shizuoka,
Shizuoka JAPAN 16 A - - -- Fish
Date Published: 08/21/2024

Desc: Ready-to-eat; shelf stable fish products Notes: HACCP violations, 11/2023 SUSHI DEN JAPAN Date Published : 08/26/2014 1 Chome 9-22 , Minato; Chuo
, Fukuoka,
Fukuoka JAPAN 16 A - - 07 Bonito
Date Published: 08/26/2014

Desc: Bonita Notes: Problem(s):
Warning Letter issued to firm on June 24, 2014 for HACCP violations
observed during February 2014 inspection. CFSAN found the firm's response
letter of July 2014 inadequate. 16 A - - 22 Mackerel (only Scomberomorus spp eg. Spanish or King)
Date Published: 08/26/2014

Desc: Spanish Mackerel Notes: Problem(s):
Warning Letter issued to firm on June 24, 2014 for HACCP violations
observed during February 2014 inspection. CFSAN found the firm's response
letter of July 2014 inadequate. 16 A - - 23 Mullet
Date Published: 08/26/2014

Desc: Jack Mackerel Notes: Problem(s):
Warning Letter issued to firm on June 24, 2014 for HACCP violations
observed during February 2014 inspection. CFSAN found the firm's response
letter of July 2014 inadequate. 16 A - - 79 Yellowtail, Amberjack
Date Published: 08/26/2014

Desc: Yellowtail Notes: Problem(s):
Warning Letter issued to firm on June 24, 2014 for HACCP violations
observed during February 2014 inspection. CFSAN found the firm's response
letter of July 2014 inadequate. Yamachika Hieda Shoten Co.,ltd. Date Published : 04/23/2010 11-3-616 3 Chome Nagahama,Chuo-Ku , Nagahama; Chuo
, Fukuoka,
Fukuoka JAPAN 16 A - - 73 Mackerel (all except Scomberomorus sp, eg Spanish or King see '22')
Date Published: 04/23/2010

Desc: Mackerel 16 A - - 76 Saury
Date Published: 04/23/2010

Desc: Saury

KAZAKHSTAN

Limited Liability Company "Name Amangeldy" Date Published : 11/15/2016 Industrial area street, Southern , House 29
, Atyrau,
Atyrau KAZAKHSTAN 16 A G H -- Fish, Plastic, Synth, Ntrl/Artfcl Dried
Date Published: 11/15/2016

Desc: Salted; Dried Fish Notes: Problem(s);
HACCP violations 16 A G P -- Fish, Plastic, Synth, Cultured/Cured
Date Published: 11/15/2016

Desc: Salted; Dried Fish Notes: Problem(s):
HACCP violations 16 A V H -- Fish, Vacuum or Modified Atmosphere Packaging, Ntrl/Artfcl Dried
Date Published: 11/15/2016

Desc: Salted; Dried Fish Notes: Problem(s);
HACCP violations 16 A V P -- Fish, Vacuum or Modified Atmosphere Packaging, Cultured/Cured
Date Published: 11/15/2016

Desc: Salted; Dried Fish Notes: Problem(s);
HACCP violations

KOREA (THE REPUBLIC OF)

Banchandanji Co. Ltd. Date Published : 02/12/2026 20 Geonji-Ro 95beon-Gil , 14 Geonji-Ro 95beon-Gil
, Seo District,
Incheon KOREA (THE REPUBLIC OF) 16 A - - 28 Pollack, Pollock
Date Published: 02/12/2026

Desc: Salted Spicy Pollock (entrails) Notes: Problem(s):
FDA inspection of this food manufacturing facility found serious deviations of the seafood HACCP regulations (21 CFR Part 123). Based on FDA?s inspectional findings and review of the firm?s response, the FDA determined that the firm?s salted spicy pollock (entrails), seasoned pollock roe, and frozen salted squid/octopus products processed in the facility appear to be adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act. Identified violations include: 21 CFR 123.6(c), inadequate CCPs, critical limits, monitoring procedures and 21 CFR 123.7(a), inadequate corrective action procedures. 16 A - - 28 Pollack, Pollock
Date Published: 02/12/2026

Desc: Seasoned Pollock Roe Notes: Problem(s):
FDA inspection of this food manufacturing facility found serious deviations of the seafood HACCP regulations (21 CFR Part 123). Based on FDA?s inspectional findings and review of the firm?s response, the FDA determined that the firm?s salted spicy pollock (entrails), seasoned pollock roe, and frozen salted squid/octopus products processed in the facility appear to be adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act. Identified violations include: 21 CFR 123.6(c), inadequate CCPs, critical limits, monitoring procedures and 21 CFR 123.7(a), inadequate corrective action procedures. 16 M - - 03 Squid, Other Aquatic Species
Date Published: 02/12/2026

Desc: Frozen Salted Squid/Octopus Notes: Problem(s):
FDA inspection of this food manufacturing facility found serious deviations of the seafood HACCP regulations (21 CFR Part 123). Based on FDA?s inspectional findings and review of the firm?s response, the FDA determined that the firm?s salted spicy pollock (entrails), seasoned pollock roe, and frozen salted squid/octopus products processed in the facility appear to be adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act. Identified violations include: 21 CFR 123.6(c), inadequate CCPs, critical limits, monitoring procedures and 21 CFR 123.7(a), inadequate corrective action procedures. 16 M - - 09 Octopus, Other Aquatic Species
Date Published: 02/12/2026

Desc: Frozen Salted Squid/Octopus Notes: Problem(s):
FDA inspection of this food manufacturing facility found serious deviations of the seafood HACCP regulations (21 CFR Part 123). Based on FDA?s inspectional findings and review of the firm?s response, the FDA determined that the firm?s salted spicy pollock (entrails), seasoned pollock roe, and frozen salted squid/octopus products processed in the facility appear to be adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act. Identified violations include: 21 CFR 123.6(c), inadequate CCPs, critical limits, monitoring procedures and 21 CFR 123.7(a), inadequate corrective action procedures. 16 N - - 03 Squid, Breaded, Other Aquatic Species
Date Published: 02/12/2026

Desc: Frozen Salted Squid/Octopus Notes: Problem(s):
FDA inspection of this food manufacturing facility found serious deviations of the seafood HACCP regulations (21 CFR Part 123). Based on FDA?s inspectional findings and review of the firm?s response, the FDA determined that the firm?s salted spicy pollock (entrails), seasoned pollock roe, and frozen salted squid/octopus products processed in the facility appear to be adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act. Identified violations include: 21 CFR 123.6(c), inadequate CCPs, critical limits, monitoring procedures and 21 CFR 123.7(a), inadequate corrective action procedures. 16 N - - 09 Octopus, Breaded, Other Aquatic Species
Date Published: 02/12/2026

Desc: Frozen Salted Squid/Octopus Notes: Problem(s):
FDA inspection of this food manufacturing facility found serious deviations of the seafood HACCP regulations (21 CFR Part 123). Based on FDA?s inspectional findings and review of the firm?s response, the FDA determined that the firm?s salted spicy pollock (entrails), seasoned pollock roe, and frozen salted squid/octopus products processed in the facility appear to be adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act. Identified violations include: 21 CFR 123.6(c), inadequate CCPs, critical limits, monitoring procedures and 21 CFR 123.7(a), inadequate corrective action procedures. 16 P - - 09 Octopus, Cakes, Balls, Etc., Other Aquatic Species
Date Published: 02/12/2026

Desc: Frozen Salted Squid/Octopus Notes: Problem(s):
FDA inspection of this food manufacturing facility found serious deviations of the seafood HACCP regulations (21 CFR Part 123). Based on FDA?s inspectional findings and review of the firm?s response, the FDA determined that the firm?s salted spicy pollock (entrails), seasoned pollock roe, and frozen salted squid/octopus products processed in the facility appear to be adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act. Identified violations include: 21 CFR 123.6(c), inadequate CCPs, critical limits, monitoring procedures and 21 CFR 123.7(a), inadequate corrective action procedures. 16 Y - - 04 Fish Roe, Fishery Products, n.e.c.
Date Published: 02/12/2026

Desc: Seasoned Pollock Roe Notes: Problem(s):
FDA inspection of this food manufacturing facility found serious deviations of the seafood HACCP regulations (21 CFR Part 123). Based on FDA?s inspectional findings and review of the firm?s response, the FDA determined that the firm?s salted spicy pollock (entrails), seasoned pollock roe, and frozen salted squid/octopus products processed in the facility appear to be adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act. Identified violations include: 21 CFR 123.6(c), inadequate CCPs, critical limits, monitoring procedures and 21 CFR 123.7(a), inadequate corrective action procedures. DAELIM FISHERIES UNION CO. Date Published : 09/21/2011 815-3, Namgok-Dong, Boryung-City , Chungnam, Korea
, Boryung-City,
KR-44 KOREA (THE REPUBLIC OF) 16 A - - 01 Anchovy
Date Published: 09/21/2011

Desc: Anchovy Donglim Seafood Corporation Date Published : 07/22/2014 Hangdong 108 3
, Inchon,
Inchon KOREA (THE REPUBLIC OF) 16 Y - - 01 Caviar, Fishery Products, n.e.c.
Date Published: 07/22/2014

Desc: Capelin Roe Notes: Violative inspection conducted at the facility in March 2014 16 Y - - 01 Caviar, Fishery Products, n.e.c.
Date Published: 07/22/2014

Desc: Flying Fish Roe Notes: Violative inspection conducted at the facility in March 2014. 16 Y - - 04 Fish Roe, Fishery Products, n.e.c.
Date Published: 07/22/2014

Desc: Capelin Roe Notes: Violative inspection conducted at the facility in March 2014. 16 Y - - 04 Fish Roe, Fishery Products, n.e.c.
Date Published: 07/22/2014

Desc: Flying Fish Roe Notes: Violative inspection conducted at the facility in March 2014. Hajung Salted Seafood Date Published : 05/31/2025 38 Gukdongnam7-Gil
, Yeosu,
Jeollanam KOREA (THE REPUBLIC OF) 16 M - - 03 Squid, Other Aquatic Species
Date Published: 05/31/2025

Desc: RTE seasoned squid Notes: Problem(s): HACCP violations, 11/2024

Foreign inspection was conducted of this seafood manufacturing facility and found serious deviations of the seafood HACCP regulations (21 CFR Part 123). Based on FDA?s inspectional findings, we have determined the listed seafood products processed in the facility are adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act), in that they were prepared, packed or held under insanitary conditions whereby they may have been contaminated with filth or whereby they may have been rendered injurious to health. Specific violations include: 21 CFR 123.6(a) and (c)(2) - the firm did not list critical control point for their refrigerated storage step, to control the food safety hazard of pathogens and 21 CFR 123.11(b) - firm did not monitor the condition and cleanliness of food contact surfaces, utensils and gloves, the protection of food, food packaging material, and food contact surfaces from adulteration with condensate; and the exclusion of pests from the food plant. 16 M - - 09 Octopus, Other Aquatic Species
Date Published: 05/31/2025

Desc: RTE seasoned octopus Notes: Problem(s): HACCP violations, 11/2024

Foreign inspection was conducted of this seafood manufacturing facility and found serious deviations of the seafood HACCP regulations (21 CFR Part 123). Based on FDA?s inspectional findings, we have determined the listed seafood products processed in the facility are adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act), in that they were prepared, packed or held under insanitary conditions whereby they may have been contaminated with filth or whereby they may have been rendered injurious to health. Specific violations include: 21 CFR 123.6(a) and (c)(2) - the firm did not list critical control point for their refrigerated storage step, to control the food safety hazard of pathogens and 21 CFR 123.11(b) - firm did not monitor the condition and cleanliness of food contact surfaces, utensils and gloves, the protection of food, food packaging material, and food contact surfaces from adulteration with condensate; and the exclusion of pests from the food plant. ILSUNG F&P Date Published : 12/31/2013 39-20 Jorimi-ro
, Gimpo-si,
Gyeonggi-do KOREA (THE REPUBLIC OF) 16 A - - 01 Anchovy
Date Published: 12/31/2013

Desc: Boiled & Dried Anchovy Jinjuham Co. Ltd. Date Published : 07/09/2025 39 Yusangongdan7-Gil
, Yangsan,
Gyeongsangnam KOREA (THE REPUBLIC OF) 16 C - - 99 Fish Cakes, Balls, Etc., N.E.C.
Date Published: 07/09/2025

Desc: Fish Sausage Notes: FDA inspection conducted of this food manufacturing facility found serious deviations of the seafood HACCP regulations (21 CFR Part 123). Based on FDA?s inspectional findings and review of the firm?s response, the FDA determined the listed seafood products processed in the facility appear adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act). Specific violations include: 21 CFR 123.6(c)(2) - HACCP plan does not list one or more critical control points that are necessary for each of the identified food safety hazards; 21 CFR 123.11(b) - not monitoring the sanitation conditions and practices with sufficient frequency to assure conformance with Current Good Manufacturing Practices including condition and cleanliness of food contact surfaces. 16 W - - 99 Mixed Fishery/Seafood Products, N.E.C.
Date Published: 07/09/2025

Desc: Fish Sausage Notes: FDA inspection conducted of this food manufacturing facility found serious deviations of the seafood HACCP regulations (21 CFR Part 123). Based on FDA?s inspectional findings and review of the firm?s response, the FDA determined the listed seafood products processed in the facility appear adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act). Specific violations include: 21 CFR 123.6(c)(2) - HACCP plan does not list one or more critical control points that are necessary for each of the identified food safety hazards; 21 CFR 123.11(b) - not monitoring the sanitation conditions and practices with sufficient frequency to assure conformance with Current Good Manufacturing Practices including condition and cleanliness of food contact surfaces. KEUM HAN Industrial Date Published : 09/29/2020 40-25 Nonggongdanji-Gil; Jumunjin-Eub
, Gangreung-Si,
Gangweon-do KOREA (THE REPUBLIC OF) 16 M - - 03 Squid, Other Aquatic Species
Date Published: 09/29/2020

Desc: Dried Squid Notes: HACCP Violations noted, May 2020 NATIONAL FEDERATION OF FISHERIES Date Published : 04/08/2011 62 Ogeum-ro
, Songpa-gu,
Seoulteugbyeol-si KOREA (THE REPUBLIC OF) 16 A - - 01 Anchovy
Date Published: 04/11/2011

Desc: Anchovy Namil General Foods Co. Date Published : 09/03/2025 20 Jangpyeongro132beon-Gil
, Saha District,
Busan KOREA (THE REPUBLIC OF) 16 A - - 21 Herring
Date Published: 09/03/2025

Desc: RTE LACF Kimchi and Pacific Saury Notes: HACCP violations.
FDA inspection of this food manufacturing facility found serious deviations of the seafood HACCP regulations (21 CFR Part 123). Based on FDA?s inspectional findings and review of the firm?s response, the FDA determined that the firm?s LACF Pacific Saury, LACF Mackerel, and LACF Kimchi and Pacific Saury products processed in the facility appear to be adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act. Specific violations include: 21 CFR 123.6(c)- The firm does not have a HACCP plan to control the hazards of Scombrotoxin (Histamine) formation and undeclared food allergens. 16 A - - 21 Herring
Date Published: 09/03/2025

Desc: RTE LACF Pacific Saury (Mackerel Pike) Notes: HACCP violations.
FDA inspection of this food manufacturing facility found serious deviations of the seafood HACCP regulations (21 CFR Part 123). Based on FDA?s inspectional findings and review of the firm?s response, the FDA determined that the firm?s LACF Pacific Saury, LACF Mackerel, and LACF Kimchi and Pacific Saury products processed in the facility appear to be adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act. Specific violations include: 21 CFR 123.6(c)- The firm does not have a HACCP plan to control the hazards of Scombrotoxin (Histamine) formation and undeclared food allergens. 16 A - - 22 Mackerel (only Scomberomorus spp eg. Spanish or King)
Date Published: 09/03/2025

Desc: RTE LACF Pacific Saury (Mackerel Pike) Notes: HACCP violations.
FDA inspection of this food manufacturing facility found serious deviations of the seafood HACCP regulations (21 CFR Part 123). Based on FDA?s inspectional findings and review of the firm?s response, the FDA determined that the firm?s LACF Pacific Saury, LACF Mackerel, and LACF Kimchi and Pacific Saury products processed in the facility appear to be adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act. Specific violations include: 21 CFR 123.6(c)- The firm does not have a HACCP plan to control the hazards of Scombrotoxin (Histamine) formation and undeclared food allergens. 16 A - - 22 Mackerel (only Scomberomorus spp eg. Spanish or King)
Date Published: 09/03/2025

Desc: RTE LACF Kimchi and Pacific Saury Notes: HACCP violations.
FDA inspection of this food manufacturing facility found serious deviations of the seafood HACCP regulations (21 CFR Part 123). Based on FDA?s inspectional findings and review of the firm?s response, the FDA determined that the firm?s LACF Pacific Saury, LACF Mackerel, and LACF Kimchi and Pacific Saury products processed in the facility appear to be adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act. Specific violations include: 21 CFR 123.6(c)- The firm does not have a HACCP plan to control the hazards of Scombrotoxin (Histamine) formation and undeclared food allergens. 16 A - - 73 Mackerel (all except Scomberomorus sp, eg Spanish or King see '22')
Date Published: 09/03/2025

Desc: RTE LACF Mackerel Notes: HACCP violations.
FDA inspection of this food manufacturing facility found serious deviations of the seafood HACCP regulations (21 CFR Part 123). Based on FDA?s inspectional findings and review of the firm?s response, the FDA determined that the firm?s LACF Pacific Saury, LACF Mackerel, and LACF Kimchi and Pacific Saury products processed in the facility appear to be adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act. Specific violations include: 21 CFR 123.6(c)- The firm does not have a HACCP plan to control the hazards of Scombrotoxin (Histamine) formation and undeclared food allergens. 16 A - - 73 Mackerel (all except Scomberomorus sp, eg Spanish or King see '22')
Date Published: 09/03/2025

Desc: RTE LACF Kimchi and Pacific Saury Notes: HACCP violations.
FDA inspection of this food manufacturing facility found serious deviations of the seafood HACCP regulations (21 CFR Part 123). Based on FDA?s inspectional findings and review of the firm?s response, the FDA determined that the firm?s LACF Pacific Saury, LACF Mackerel, and LACF Kimchi and Pacific Saury products processed in the facility appear to be adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act. Specific violations include: 21 CFR 123.6(c)- The firm does not have a HACCP plan to control the hazards of Scombrotoxin (Histamine) formation and undeclared food allergens. 16 A - - 76 Saury
Date Published: 09/03/2025

Desc: RTE LACF Pacific Saury (Mackerel Pike) Notes: HACCP violations.
FDA inspection of this food manufacturing facility found serious deviations of the seafood HACCP regulations (21 CFR Part 123). Based on FDA?s inspectional findings and review of the firm?s response, the FDA determined that the firm?s LACF Pacific Saury, LACF Mackerel, and LACF Kimchi and Pacific Saury products processed in the facility appear to be adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act. Specific violations include: 21 CFR 123.6(c)- The firm does not have a HACCP plan to control the hazards of Scombrotoxin (Histamine) formation and undeclared food allergens. 16 A - - 76 Saury
Date Published: 09/03/2025

Desc: RTE LACF Kimchi and Pacific Saury Notes: HACCP violations.
FDA inspection of this food manufacturing facility found serious deviations of the seafood HACCP regulations (21 CFR Part 123). Based on FDA?s inspectional findings and review of the firm?s response, the FDA determined that the firm?s LACF Pacific Saury, LACF Mackerel, and LACF Kimchi and Pacific Saury products processed in the facility appear to be adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act. Specific violations include: 21 CFR 123.6(c)- The firm does not have a HACCP plan to control the hazards of Scombrotoxin (Histamine) formation and undeclared food allergens. Narae Traditional Food Co. Ltd. Date Published : 06/28/2012 1363-14 , Pyeungsa-ri Dolsan eup
, Yeosu City,
Jeollanam-do KOREA (THE REPUBLIC OF) 16 A - - 56 Filefish
Date Published: 10/21/2012

Desc: Filefish Samhong Industrial Co., Ltd. Date Published : 03/13/2009 1062 Hupo-Ri, Hupo-Myun
, Ulchin,
Kyungsangbuk KOREA (THE REPUBLIC OF) 16 L - - 01 Crab, Cakes, Balls, Etc.
Date Published: 09/17/2021

Desc: Cooked Sandwich Packed Crabmeat Notes: 12/03/2001 Seorak Clean Food Date Published : 05/23/2014 Nohakdong 950
, Sokcho,
Kangwon KOREA (THE REPUBLIC OF) 16 M - - 03 Squid, Other Aquatic Species
Date Published: 05/23/2014

Desc: Squid sausage ShinWoo Agri-Fishery Co.,Ltd. Date Published : 03/26/2024 Dadaedong-ro 6beon-gil
, Saja-gu,
Busan Gwangyeogsi KOREA (THE REPUBLIC OF) 16 A - - 28 Pollack, Pollock
Date Published: 03/26/2024

Desc: Dried Pollack Notes: HACCP violations; 3/21/2024 Shinhan F&B Co., Ltd. Date Published : 01/11/2013 11-3,Sangpoom Ri , Sanbook-Myeon Yeoju-Kun
, Gyounggi-Do,
Kr-41 KOREA (THE REPUBLIC OF) 16 M - - 03 Squid, Other Aquatic Species
Date Published: 01/11/2013

Desc: Vacuum Packaged roasted squid Sungjin Fishery Co., Ltd. Date Published : 03/13/2009 167-23, Machun-dong, , Jinhae-city
, Kyungsangnam-do,
KOREA (THE REPUBLIC OF) 16 R - - 02 Crab, Imitation
Date Published: 03/13/2009

Notes: Imitation crab sticks/breaded crab

5/1/2001 16 R - - 03 Shrimp, Imitation
Date Published: 03/13/2009

Notes: Imitation shrimp

5/1/2001 16 R - - 04 Lobster, Imitation
Date Published: 03/13/2009

Notes: Imitation lobster

5/1/2001 16 R - - 99 Other Engineered Seafood Products, N.E.C.
Date Published: 03/13/2009

Notes: 5/1/2001 Taerim Co., Ltd. Date Published : 03/13/2009 1060 Hupo-ri, Hupo-myun , Kyung buk
, Ulchin-gun,
KOREA (THE REPUBLIC OF) 16 J - N 01 Crab, Heat Treated
Date Published: 09/17/2021

Desc: Crab Cooked (in frozen blocks) Notes: 1/8/2002 16 J - O 01 Crab, Pasteurized
Date Published: 09/17/2021

Desc: Crab Cooked (in frozen blocks) Notes: 1/8/2002 The Ocean Co Ltd Date Published : 12/22/2017 54 Wanjeongro, 2-Gil, Seo-Gu
, Incheon,
Incheon KOREA (THE REPUBLIC OF) 16 A - - 16 Flounder (Arrowtooth, Dab, Fluke)
Date Published: 04/17/2020

Desc: Flounder (live or processed) Notes: HACCP Violations 16 A - - 46 Turbot
Date Published: 04/17/2020

Desc: Turbot (live or processed) Notes: HACCP Violations 16 X - - 99 Aquaculture Harvested Fishery/Seafood Products, N.E.C.,
Date Published: 04/17/2020

Desc: Flounder (live or processed) Notes: HACCP Violations 16 X - - 99 Aquaculture Harvested Fishery/Seafood Products, N.E.C.,
Date Published: 04/17/2020

Desc: Turbot (live or processed) Notes: HACCP Violations Yongdae Hwangtae Union Corp Daeryung Date Published : 04/01/2025 10-30 Wontongro74beon-Gil , Bung-Myeon
, Inje,
Gangwon KOREA (THE REPUBLIC OF) 16 A V - 28 Pollack, Pollock, Vacuum or Modified Atmosphere Packaging
Date Published: 04/01/2025

Desc: refrigerated and frozen desalted Pollock in modified atmosphere packaging products Notes: HACCP violations, 1/2025

LATVIA

OOO "Elanders" Date Published : 01/23/2024 Jaunciema gatve 320
, Riga,
Rigas rajons LATVIA 16 A - - 21 Herring
Date Published: 01/23/2024

Desc: Refrigerated salted herring in marinade solution Notes: HACCP Violations; July 2022 16 S - - 22 Mackerel, Cold Smoked, Fish (only Scomberomorus spp eg. Spanish or King)
Date Published: 01/23/2024

Desc: Refrigerated vacuum-packed cold smoked mackerel Notes: HACCP Violations; July 2022 SIA Karavela Date Published : 11/16/2009 Street , Atlantijas Iela 15
, Riga,
Riga LATVIA 16 A - - 21 Herring
Date Published: 11/16/2009

Desc: Canned herring Notes: 2/11/2004 16 A - - 22 Mackerel (only Scomberomorus spp eg. Spanish or King)
Date Published: 11/16/2009

Desc: Canned mackeral Notes: 2/11/2004 16 A - - 73 Mackerel (all except Scomberomorus sp, eg Spanish or King see '22')
Date Published: 11/16/2009

Desc: Canned mackeral Notes: 2/11/2004 16 A - - 99 Fish, N.E.C.
Date Published: 11/12/2015

Desc: Herring 16 A - - 99 Fish, N.E.C.
Date Published: 11/12/2015

Desc: Mackeral; Spanish or King 16 A - - 99 Fish, N.E.C.
Date Published: 11/12/2015

Desc: Mackerel (all except Spanish or King) Sabiles ADK Ltd. Date Published : 03/13/2009 20 Rigas Str. Sabile
, Talsi,
LATVIA 16 - - - -- Fishery/Seafood Products
Date Published: 03/13/2009

Notes: 5/14/2002

MALAYSIA

ES Food Industries Sdn Bhd Date Published : 06/09/2025 No. 11, Section 26 (Hicom) , Persiaran Sabak Bernam
, Shah Alam,
Selangor MALAYSIA 16 Y - - 12 Shrimp Paste, Fishery Products, n.e.c.
Date Published: 06/09/2025

Desc: Ready-to-eat shelf-stable Seafood Cooking Paste in 200g/(7oz) nylon plastic flexible hermetically sealed pouches. Cheffaro Curry Laksa Paste Notes: Problem(s): HACCP violations 1/2025

Firm is added to Import Alert #16-120 after an FDA inspection conducted on January 17 to 21, 2025 of this food manufacturing facility found serious deviations of the seafood HACCP regulations (21 CFR Part 123). On February 14 2025 the firm responded to the violative inspection conducted January 17 to 21 2025 which included a revised HACCP plan. Based on FDA?s inspectional findings and review of the firm?s response we have determined the listed seafood products processed in the facility appear adulterated within the meaning of section 402(a)(4) of the Federal Food Drug, and Cosmetic Act (the Act) [21 U.S.C.?342(a)(4)]. Specific violations include: 21 CFR 123.6(c) ? The firm does not have a HACCP plan to control the hazards of pathogen growth/toxin formation (Clostridium botulinum) and undeclared food allergens; and 21 CFR 123.11(b) ? The firm is not monitoring the sanitizing of food-contact surfaces with sufficient frequency. 16 Y - - 12 Shrimp Paste, Fishery Products, n.e.c.
Date Published: 06/09/2025

Desc: Ready-to-eat shelf-stable Seafood Cooking Paste in 200g/(7oz) nylon plastic flexible hermetically sealed pouches. Cheffaro Prawn Noodle Paste Notes: Problem(s): HACCP violations 1/2025

Firm is added to Import Alert #16-120 after an FDA inspection conducted on January 17 to 21, 2025 of this food manufacturing facility found serious deviations of the seafood HACCP regulations (21 CFR Part 123). On February 14 2025 the firm responded to the violative inspection conducted January 17 to 21 2025 which included a revised HACCP plan. Based on FDA?s inspectional findings and review of the firm?s response we have determined the listed seafood products processed in the facility appear adulterated within the meaning of section 402(a)(4) of the Federal Food Drug, and Cosmetic Act (the Act) [21 U.S.C.?342(a)(4)]. Specific violations include: 21 CFR 123.6(c) ? The firm does not have a HACCP plan to control the hazards of pathogen growth/toxin formation (Clostridium botulinum) and undeclared food allergens; and 21 CFR 123.11(b) ? The firm is not monitoring the sanitizing of food-contact surfaces with sufficient frequency. 37 K - - 23 Curry Paste
Date Published: 06/09/2025

Desc: Ready-to-eat shelf-stable Seafood Cooking Paste in 200g/(7oz) nylon plastic flexible hermetically sealed pouches. Cheffaro Curry Laksa Paste Notes: Problem(s): HACCP violations 1/2025

Firm is added to Import Alert #16-120 after an FDA inspection conducted on January 17 to 21, 2025 of this food manufacturing facility found serious deviations of the seafood HACCP regulations (21 CFR Part 123). On February 14 2025 the firm responded to the violative inspection conducted January 17 to 21 2025 which included a revised HACCP plan. Based on FDA?s inspectional findings and review of the firm?s response we have determined the listed seafood products processed in the facility appear adulterated within the meaning of section 402(a)(4) of the Federal Food Drug, and Cosmetic Act (the Act) [21 U.S.C.?342(a)(4)]. Specific violations include: 21 CFR 123.6(c) ? The firm does not have a HACCP plan to control the hazards of pathogen growth/toxin formation (Clostridium botulinum) and undeclared food allergens; and 21 CFR 123.11(b) ? The firm is not monitoring the sanitizing of food-contact surfaces with sufficient frequency. 37 K - - 99 Pastes, n.e.c.
Date Published: 06/09/2025

Desc: Ready-to-eat shelf-stable Seafood Cooking Paste in 200g/(7oz) nylon plastic flexible hermetically sealed pouches. Cheffaro Prawn Noodle Paste Notes: Problem(s): HACCP violations 1/2025

Firm is added to Import Alert #16-120 after an FDA inspection conducted on January 17 to 21, 2025 of this food manufacturing facility found serious deviations of the seafood HACCP regulations (21 CFR Part 123). On February 14 2025 the firm responded to the violative inspection conducted January 17 to 21 2025 which included a revised HACCP plan. Based on FDA?s inspectional findings and review of the firm?s response we have determined the listed seafood products processed in the facility appear adulterated within the meaning of section 402(a)(4) of the Federal Food Drug, and Cosmetic Act (the Act) [21 U.S.C.?342(a)(4)]. Specific violations include: 21 CFR 123.6(c) ? The firm does not have a HACCP plan to control the hazards of pathogen growth/toxin formation (Clostridium botulinum) and undeclared food allergens; and 21 CFR 123.11(b) ? The firm is not monitoring the sanitizing of food-contact surfaces with sufficient frequency. International Trading & Manufacturing Co. Date Published : 11/16/2009 Bagan Bukit Tambun 15
, Simpang Ampat,
Pulau Pinang MALAYSIA 16 - - - -- Fishery/Seafood Products
Date Published: 11/16/2009

Desc: All seafood products Notes: 10/21/2008 Ket Hoe Trading Sdn Bhd Date Published : 08/11/2017 48 Jalan Dr Lim Chwee Leong
, Pulau Pinang,
Pulau Pinang MALAYSIA 16 Y - - 12 Shrimp Paste, Fishery Products, n.e.c.
Date Published: 08/11/2017

Desc: Fruit Dressing; Sambal Rojak; "Shrimp & Boy Brand" Notes: Problem(s);
HACCP violations 16 Y - - 12 Shrimp Paste, Fishery Products, n.e.c.
Date Published: 08/11/2017

Desc: Shrimp paste; Prawn Paste; Petis Udang ; "Shrimp & Boy Brand" Notes: Problem(s);
HACCP violations Sen Up Huat Seafood Trading Sdn Bhd Date Published : 08/13/2024 Lot 9999, Jalan Tepi Sungai
, Hutan Melintang,
Perak MALAYSIA 16 A - - 07 Bonito
Date Published: 08/13/2024

Desc: Fresh and frozen Bonito and all histamine forming seafood products Notes: HACCP violations; 10/23-24/2023 16 A - - 99 Fish, N.E.C.
Date Published: 08/13/2024

Desc: Fresh and frozen Bonito and all histamine forming seafood products Notes: HACCP violations; 10/23-24/2023 16 A - - -- Fish
Date Published: 08/13/2024

Desc: Fresh and frozen Bonito and all histamine forming seafood products Notes: HACCP violations; 10/23-24/2023

MEXICO

Expormar, S.A. De C.V. Date Published : 03/13/2009 Domicilio Conocido La Playita Poste #37
, La Reforma Ang. Sinaloa,
MEXICO 16 J - - 01 Crab
Date Published: 03/13/2009

Notes: Cooked crabmeat

1/12/2007 INTERMARKETING DE MEXICO, S.A. DE C.V. Date Published : 03/13/2009 Calle 10 # 235 , Parque Industrial Fondeport El Sauzal,
, Ensenada,
Mx-Bcn MEXICO 16 A - - -- Fish
Date Published: 09/13/2021

Desc: All scombrotoxin forming fish species Notes: 9/4/2008 Marlin Y Atun Ahumado Dofia Jovita Date Published : 03/13/2009 Compra Venta De Pescado Mahi 8 Cos Y
, Ejido El Castillo Mazatlan,
MEXICO 16 S G P 45 Tuna (Albacore, Yellowfin, Bluefin, Skipjack, etc.), Cold Smoked, Fish, Plastic, Synth, Cultured/Cured
Date Published: 09/14/2021

Desc: Vacuum packed smoked tuna Notes: 6/19/2001 16 S V P 45 Tuna (Albacore, Yellowfin, Bluefin, Skipjack, etc.), Cold Smoked, Fish, Vacuum or Modified Atmosphere Packaging, Cultured/Cured
Date Published: 09/14/2021

Desc: Vacuum packed smoked tuna Notes: 6/19/2001

MOROCCO

Consernor Date Published : 03/31/2010 160 Route Du Djorf El Youdi BP 56
, Safi,
Safi MOROCCO 16 - - E -- Fishery/Seafood Products, Commercially Sterile
Date Published: 09/01/2021

Desc: All Canned Seafood Products; Consernor I

MOZAMBIQUE

PESCAMOZ LDA Date Published : 02/01/2024 Largo Dos Cfm Centro , Cais No 1 Cidade
, Beira,
Sofala MOZAMBIQUE 16 A - - 42 Swordfish
Date Published: 02/01/2024

Desc: Swordfish Notes: HACCP Violations; June 2023 16 A - - 45 Tuna (Albacore, Yellowfin, Bluefin, Skipjack, Etc.)
Date Published: 02/01/2024

Desc: Tuna Notes: HACCP Violations; June 2023

NICARAGUA

Baits & Sea Foods S.A. Date Published : 10/06/2023 Km. 25 Tipitapa-Masaya Highway , Parque Industrial Astro, Nave 24c
, Tipitapa,
Managua NICARAGUA 16 A - - 51 Mahi Mahi
Date Published: 10/06/2023

Desc: Fresh and Frozen Histamine Forming Seafood Products Notes: HACCP violations, 5/11/2023 16 A - - -- Fish
Date Published: 10/06/2023

Desc: Fresh and Frozen Histamine Forming Seafood Products Notes: HACCP violations, 5/11/2023 CR Grupo Comercial Alvacora SA Date Published : 01/12/2023 Sabana Grande De La Reinter 500 Metros Al Su.
, Managua,
NICARAGUA 16 M - - 10 Sea Cucumber, Other Aquatic Species
Date Published: 01/12/2023

Desc: Dry Sea Cucumber Compania Pesquera Charly Sociedad Anonima - COPESCHARLY S.A. Date Published : 12/21/2023 Calle Principal Al Colegio Inhco , Sandino Neighborhood Main Street To The School Inhco, Bilwi
, Puerto Cabezas,
Atlantico Norte NICARAGUA 16 M - - 10 Sea Cucumber, Other Aquatic Species
Date Published: 12/21/2023

Desc: Sea Cucumber Notes: HACCP violations, January 2023 Man Kang, S. A. Date Published : 04/04/2025 Km 21 Carretera A Masaya, 3 Km Al Norte, 119.5 Meters A Este
, Nindiri,
Masaya NICARAGUA 16 M - - 10 Sea Cucumber, Other Aquatic Species
Date Published: 04/04/2025

Desc: Sea Cucumber Notes: HACCP violations, 11/2024 16 N - - 10 Sea Cucumber, Breaded, Other Aquatic Species
Date Published: 04/04/2025

Desc: Sea Cucumber Notes: HACCP violations, 11/2024 16 V - - 10 Sea Cucumber, Cold Smoked, Other Aquatic Species
Date Published: 04/04/2025

Desc: Sea Cucumber Notes: HACCP violations, 11/2024 Rey de los Camarones S.A. Date Published : 01/24/2025 Kilometer 9 Of The New Road To Leon, In Front Of The New York Motel, Barrio Xavier Gruta
, Ciudad Sandino,
Managua NICARAGUA 16 M - - 10 Sea Cucumber, Other Aquatic Species
Date Published: 01/24/2025

Desc: All dried and salted sea cucumber products Notes: HACCP violations, 08/26 ? 08/30, 2024 16 M - - 99 Other Aquatic Animals, N.E.C.
Date Published: 01/24/2025

Desc: All dried and salted sea cucumber products Notes: HACCP violations, 08/26 ? 08/30, 2024 16 V - - 10 Sea Cucumber, Cold Smoked, Other Aquatic Species
Date Published: 01/24/2025

Desc: All dried and salted sea cucumber products Notes: HACCP violations, 08/26 ? 08/30, 2024 16 V - - 99 Other Aquatic Species, Cold Smoked, N.E.C.
Date Published: 01/24/2025

Desc: All dried and salted sea cucumber products Notes: HACCP violations, 08/26 ? 08/30, 2024

NORWAY

GJENDEMSJOE FISK AS Date Published : 08/30/2011 Synnalandsveien
, Brattvaag,
More og Romsdal NORWAY 16 I - - 32 Salmon (Humpback, Silver, King Sockeye, etc.), Hot Smoked, Fish
Date Published: 08/30/2011

Desc: Hot Smoked Salmon 16 S - - 32 Salmon (Humpback, Silver, King, Sockeye, etc.), Cold Smoked, Fish
Date Published: 08/30/2011

Desc: Hot Smoked Salmon Grytestranda Fiskeindustri AS Date Published : 08/01/2011 Grytestranda , Vatne 6265
, Vatne,
More og Romsdal NORWAY 16 A - - 12 Cod
Date Published: 08/01/2011

Desc: Salted Dried Cod (Klippfisk) Njardar Date Published : 08/18/2011 Naeroy
, Leinoy,
None of the above NORWAY 16 A - - 21 Herring
Date Published: 08/18/2011

Desc: Salted Herring Products 16 I - - 21 Herring, Hot Smoked, Fish
Date Published: 08/18/2011

Desc: Smoked Herring Products 16 S - - 21 Herring, Cold Smoked, Fish
Date Published: 08/18/2011

Desc: Smoked Herring Products 16 Y - - 04 Fish Roe, Fishery Products, n.e.c.
Date Published: 08/18/2011

Desc: Herring Roe Seafood Farmers of Norway AS Date Published : 07/27/2011 Oksnes
, Valderoy,
More og Romsdal NORWAY 16 I - - 32 Salmon (Humpback, Silver, King Sockeye, etc.), Hot Smoked, Fish
Date Published: 07/27/2011

Desc: Hot Smoked Salmon Sevrin Tranvag AS Date Published : 10/05/2015 Tranvagen 6
, Fiskarstrand,
NO-NOTA NORWAY 16 A - - 73 Mackerel (all except Scomberomorus sp, eg Spanish or King see '22')
Date Published: 10/05/2015

Desc: All Mackerel Products

PANAMA

Gabrimar Export Fish S.A. Date Published : 02/28/2012 Puerto De Remedios , Ruc 4-226-262 D.V. 78
, Remedios,
Chiriqui PANAMA 16 A - - 51 Mahi Mahi
Date Published: 02/28/2012

Desc: Mahi Mahi Green Bay International, S.A. Date Published : 12/14/2011 Barrio Acapulco, Puerto Pedregal
, David,
Provincia de Chiriqui PANAMA 16 A - - 99 Fish, N.E.C.
Date Published: 03/28/2016

Desc: Wahoo Inversiones del Mar Pacifico, S.A. (I.M.P.S.A) Date Published : 03/01/2012 Vil Principal , Puerto Pedregal
, David,
Provincia de Chiriqui PANAMA 16 A - - 51 Mahi Mahi
Date Published: 03/01/2012

Desc: Mahi Manabi Export Panama S.A. Date Published : 12/02/2024 Edificio 17, Local 2 , Via Brasil; San Francisco
, Panama City,
Panama PANAMA 16 E - - 02 Clams
Date Published: 12/02/2024

Desc: Clam Meat Notes: HACCP violations; 4/2024 16 Y - - 14 Clam Paste, Fishery Products, n.e.c.
Date Published: 12/02/2024

Desc: Clam Meat Notes: HACCP violations; 4/2024 NALMA, S.A. Date Published : 05/06/2014 Via El Puerto- Aguadulce
, Aguadulce,
Cocle PANAMA 16 A - - 45 Tuna (Albacore, Yellowfin, Bluefin, Skipjack, Etc.)
Date Published: 05/06/2014

Desc: All Tuna Products New Life Corporation Date Published : 08/29/2012 Antigua Tiburonera , Pedregal
, David,
Provincia de Chiriqui PANAMA 16 A - - 01 Anchovy
Date Published: 08/30/2012

Notes: All histamine producing fish species 16 A - - 05 Blue Fish
Date Published: 08/30/2012

Notes: All histamine producing fish species 16 A - - 07 Bonito
Date Published: 08/30/2012

Desc: All histamine producing fish species 16 A - - 21 Herring
Date Published: 08/30/2012

Desc: All histamine producing fish species 16 A - - 22 Mackerel (only Scomberomorus spp eg. Spanish or King)
Date Published: 08/30/2012

Desc: All histamine producing fish species 16 A - - 33 Sardines (Brisling, Sprats, Pilchards, Etc.)
Date Published: 08/30/2012

Desc: All histamine producing fish species 16 A - - 37 Snapper (Red, Gray, Malabar, etc.)
Date Published: 08/30/2012

Desc: All histamine producing fish species 16 A - - 45 Tuna (Albacore, Yellowfin, Bluefin, Skipjack, Etc.)
Date Published: 08/30/2012

Desc: All histamine producing fish species 16 A - - 51 Mahi Mahi
Date Published: 08/30/2012

Desc: All histamine producing fish species 16 A - - 54 Marlin
Date Published: 08/30/2012

Desc: All histamine producing fish species 16 A - - 59 Scad
Date Published: 08/30/2012

Desc: All histamine producing fish species 16 A - - 69 Escolar
Date Published: 08/30/2012

Desc: All histamine producing fish species 16 A - - 70 Shad, Alewife
Date Published: 08/30/2012

Desc: All histamine producing fish species 16 A - - 71 Jack
Date Published: 08/30/2012

Desc: All histamine producing fish species 16 A - - 76 Saury
Date Published: 08/30/2012

Desc: All histamine producing fish species 16 A - - 78 Wahoo
Date Published: 08/30/2012

Desc: All histamine producing fish species 16 A - - 79 Yellowtail, Amberjack
Date Published: 08/30/2012

Desc: All histamine producing fish species 16 A - - 86 Sculpin
Date Published: 08/30/2012

Desc: All histamine producing fish species 16 A - - 87 Patagonian Toothfish, Chilean Seabass
Date Published: 08/30/2012

Desc: All histamine producing fish species 16 A - - 88 Gemfish
Date Published: 08/30/2012

Desc: All histamine producing fish species 16 A - - 89 Kahawa
Date Published: 08/30/2012

Desc: All histamine producing fish species 16 A - - 90 Sailfish
Date Published: 08/30/2012

Desc: All histamine producing fish species 16 A - - 91 Spearfish
Date Published: 08/30/2012

Desc: All histamine producing fish species 16 A - - 92 Trevally
Date Published: 08/30/2012

Desc: All histamine producing fish species Pacific Export Corporation Date Published : 01/20/2017 El Puerto
, Remedios,
Provincia de Chiriqui PANAMA 16 A - - 45 Tuna (Albacore, Yellowfin, Bluefin, Skipjack, Etc.)
Date Published: 01/20/2017

Desc: Tuna 16 A - - 51 Mahi Mahi
Date Published: 01/20/2017

Desc: Mahi Mahi Pacific Tropical Fish S.A. Date Published : 09/21/2011 Boca De Parita, Monagrillo
, Chitre,
Provincia De Herrera PANAMA 16 A - - 51 Mahi Mahi
Date Published: 09/21/2011

Desc: Mahi Mahi

PERU

Inversiones Peru Pacifico S.A Date Published : 12/05/2014 Calle 3,Mz D, Lote,1,2,3,6 Y 13 - Parque
, Sullana,
Piura PERU 16 A - - 51 Mahi Mahi
Date Published: 12/05/2014

Desc: Mahi Mahi Notes: Problem(s);
Firm ruled not in compliance with seafood HACCP as result of violative inspection in February 2014.
Firm issued a warning letter; response inadequate. Maquimar S.A. Date Published : 03/13/2009 Avenida Acapulco No. 150
, Callao,
Callao PERU 16 A - - 01 Anchovy
Date Published: 03/13/2009

Notes: Canned anchoveis labeled as sardines

4/7/2004 PROVEEDORA DE PRODUCTOS MARINOS SAC Date Published : 09/28/2016 Zona Industrial Ii Mz A Lote 3 Paita
, Paita,
Piura PERU 16 A - - 01 Anchovy
Date Published: 09/28/2016

Desc: Anchovy Notes: Problem: CFSAN states firm did not adequately address deviations observed
during March; 2016 foreign inspection. 16 A - - 22 Mackerel (only Scomberomorus spp eg. Spanish or King)
Date Published: 09/28/2016

Desc: Mackerel Notes: Problem: CFSAN states firm did not adequately address deviations observed
during March; 2016 foreign inspection. 16 A - - 73 Mackerel (all except Scomberomorus sp, eg Spanish or King see '22')
Date Published: 09/28/2016

Desc: Mackerel Notes: Problem: CFSAN states firm did not adequately address deviations observed
during March; 2016 foreign inspection.

PHILIPPINES

Rufina and Co.. dba Rufina Patis Factory Date Published : 11/06/2013 290 C Arellano Street
, Metro Manila,
National Capital Region PHILIPPINES 16 Y - - 09 Fish Sauce, Fishery Products, n.e.c.
Date Published: 11/06/2013

Desc: Fish Sauce Smi Fish Industries Inc Date Published : 03/13/2009 2614 Suez Street , Cor Kakarong
, Metro Manila,
PHILIPPINES 16 X - D 21 Shrimp and prawns, Aquaculture Harvested Fishery/Seafood Products, Raw - Fresh, Frozen, Natural State
Date Published: 09/17/2021

Desc: Frozen Raw Shrimp (aquaculture) Notes: 12/18/2000 16 X - T 21 Shrimp and prawns, Aquaculture Harvested Fishery/Seafood Products, Packaged Food (Not Commercially Sterile)
Date Published: 09/17/2021

Desc: Frozen Raw Shrimp (aquaculture) Notes: 12/18/2000

POLAND

Przetworstwo Ryb Proryb Date Published : 06/28/2012 Ul. Zakopianska 1
, Rumia,
Pomorskie POLAND 16 A - - 21 Herring
Date Published: 06/28/2012

Desc: Pickled Herring Wilbo S.A. Date Published : 05/24/2018 Ul. Hutnicza 22
, Gdynia,
Pomorskie POLAND 16 A - - 21 Herring
Date Published: 05/24/2018

Desc: Herring Notes: Warning Letter issued to firm on August 8; 2017; for HACCP violations. 16 A - - 22 Mackerel (only Scomberomorus spp eg. Spanish or King)
Date Published: 05/24/2018

Desc: Mackerel Notes: Warning Letter issued to firm on August 8; 2017; for HACCP violations. 16 A - - 33 Sardines (Brisling, Sprats, Pilchards, Etc.)
Date Published: 05/24/2018

Desc: Sprat Notes: Warning Letter issued to firm on August 8; 2017; for HACCP violations 16 A - - 73 Mackerel (all except Scomberomorus sp, eg Spanish or King see '22')
Date Published: 05/24/2018

Desc: Mackerel Notes: Warning Letter issued to firm on August 8; 2017; for HACCP violations.

RUSSIA

OOO "TD Baltiyskiy Bereg" Date Published : 10/16/2018 29 ,B 2 , ul. Mineralnaya
, Sankt-Peterburg,
Sankt-Peterburg RUSSIA 16 A - - 21 Herring
Date Published: 10/16/2018

Desc: Ready-to-Eat Herring in Oil Products Notes: HACCP Violations noted; April 2018

SAUDI ARABIA

A.Al Faris Group of Industries Date Published : 06/07/2013 Abu Hadriyah Highway
, Dammam,
SA-04 SAUDI ARABIA 16 Y - - 01 Caviar, Fishery Products, n.e.c.
Date Published: 06/07/2013

Desc: Caviar products

SENEGAL

Ets Mandiang & Freres Sarl Date Published : 09/16/2014 Kawsara Laye Canberene , Boite Postale 2266
, Dakar,
Dakar SENEGAL 16 - - - -- Fishery/Seafood Products
Date Published: 09/16/2014

Desc: All fishery products Notes: Firm failed to respond to 483 items issued after OAI inspection.

SINGAPORE

EE HUI FOOD MANUFACTURE PTE LTD Date Published : 02/11/2020 58 Senoko Drive , Senoko Industrial Estate
, Singapore,
SG-NA SINGAPORE 16 C - - 99 Fish Cakes, Balls, Etc., N.E.C.
Date Published: 02/11/2020

Desc: Fried Fish Ball Notes: HACCP Violations noted, June 2019 16 C - - 99 Fish Cakes, Balls, Etc., N.E.C.
Date Published: 02/11/2020

Desc: Bean Curd Fish Fingers Notes: HACCP Violations noted, June 2019 16 C - - 99 Fish Cakes, Balls, Etc., N.E.C.
Date Published: 02/11/2020

Desc: Fish Ball Notes: HACCP Violations noted, June 2019 16 C - - 99 Fish Cakes, Balls, Etc., N.E.C.
Date Published: 02/11/2020

Desc: Bean Curd Fish Cake Notes: HACCP Violations noted, June 2019 16 C - - 99 Fish Cakes, Balls, Etc., N.E.C.
Date Published: 02/11/2020

Desc: Bean Curd Fish Puff Notes: HACCP Violations noted, June 2019 16 C - - 99 Fish Cakes, Balls, Etc., N.E.C.
Date Published: 02/11/2020

Desc: Cuttlefish Ball Notes: HACCP Violations noted, June 2019 16 C - - 99 Fish Cakes, Balls, Etc., N.E.C.
Date Published: 02/11/2020

Desc: Bean Curd Cuttlefish Roll Notes: HACCP Violations noted, June 2019 16 L - - 05 Shrimp & Prawns, Cakes, Balls, Etc.
Date Published: 02/11/2020

Desc: Shrimp Ball Notes: HACCP Violations noted, June 2019 16 P - - 07 Cuttlefish, Cakes, Balls, Etc., Other Aquatic Species
Date Published: 02/11/2020

Desc: Cuttlefish Ball Notes: HACCP Violations noted, June 2019 16 R - - 01 Surimi (Used for Further Processing into Imitation Seafood)
Date Published: 02/11/2020

Desc: Surimi based fish and fishery products Notes: HACCP Violations noted, June 2019 16 W - - 99 Mixed Fishery/Seafood Products, N.E.C.
Date Published: 02/11/2020

Desc: Handmade Shrimp Roll Notes: HACCP Violations noted, June 2019 Leong Hin Foodstuff Supplier Pte Ltd Date Published : 03/13/2009 18 Woodlands Terrace
, Singapore,
SINGAPORE 16 R - - -- Engineered Seafood
Date Published: 03/13/2009

Desc: cooked surimi Notes: 7/22/2004

SOUTH AFRICA

Commercial Cold Storage Date Published : 03/13/2009 Duncan Road,
, Port of Cape Town,
SOUTH AFRICA 16 A - - 45 Tuna (Albacore, Yellowfin, Bluefin, Skipjack, Etc.)
Date Published: 03/13/2009

Notes: 11/21/2001 Dried Ocean Products Date Published : 03/13/2009 9 Mykonos Pier Street, Plot #4, Shed 1 , Airport Company
, Port Elizabeth,
SOUTH AFRICA 16 E - - 01 Abalone
Date Published: 03/13/2009

Notes: Dried abalone

1/2/2004 16 E - - 09 Abalone - style Shellfish (Concholepas concholepas)
Date Published: 03/13/2009

Notes: Dried abalone

1/2/2004 16 F - - 01 Abalone, Breaded
Date Published: 03/13/2009

Notes: Dried abalone

1/2/2004 16 F - - 09 Abalone-style shellfish (Concholepas concholepas), Breaded
Date Published: 11/19/2009

Notes: Dried abalone

1/2/2004 16 G - - 01 Abalone, Cakes, Balls, Etc.
Date Published: 03/13/2009

Notes: Dried abalone

1/2/2004 16 G - - 09 Abalone-style shellfish (Concholepas concholepas), Cakes, Balls, Etc.
Date Published: 03/13/2009

Notes: Dried abalone

1/2/2004 16 O - - 01 Abalone, Hot Smoked, Shellfish
Date Published: 03/13/2009

Notes: Dried abalone

1/2/2004 16 T - - 01 Abalone, Cold Smoked, Shellfish
Date Published: 03/13/2009

Notes: Dried abalone

1/2/2004 16 T - - 09 Abalone-style shellfish (Concholepas concholepas), Cold Smoked, Shellfish
Date Published: 03/13/2009

Notes: Dried abalone

1/2/2004 Kaytrad Commodities (Pty) Ltd. Date Published : 11/16/2009 Yorke Point Rd. (P.O. Box 6501) , Roggebaai, Hout Bay
, Cape Town,
Cape SOUTH AFRICA 16 A - - 45 Tuna (Albacore, Yellowfin, Bluefin, Skipjack, Etc.)
Date Published: 11/16/2009

Notes: 4/29/2002

SPAIN

Alesan Artesanos SL Date Published : 10/19/2016 Poligono Industrial 8 , B 7
, Ablitas,
Navarra SPAIN 16 A - E 07 Bonito, Commercially Sterile
Date Published: 10/19/2016

Desc: Canned Bonito Notes: Problems; HACCP Violations 16 A - E 33 Sardines (Brisling, Sprats, Pilchards, Etc.), Commercially Sterile
Date Published: 10/19/2016

Desc: Canned Sardines Notes: Problems; HACCP Violations 16 A - E 45 Tuna (Albacore, Yellowfin, Bluefin, Skipjack, Etc.), Commercially Sterile
Date Published: 10/19/2016

Desc: Canned Albacore Notes: Problems; HACCP Violations Anfele, S.A. Date Published : 04/30/2025 Calle La Baneza 48
, Fuenlabrada,
Madrid SPAIN 16 A - - 01 Anchovy
Date Published: 04/30/2025

Desc: Anchovies in Vinegar; Anchovies in Vinegar and Oil and Dressed Anchovies Vinegar packaged in plastic formed trays with heat sealed film (reduced oxygen packaging). Notes: HACCP violations 09/26 ? 09/27, 2024 BACALAO GIRALDO, S.L.U. Date Published : 11/18/2024 Pol. Ind. Goiain , San Blas No. 7 Int, Goiain
, Legutiano,
Alava SPAIN 16 A - - 12 Cod
Date Published: 11/18/2024

Desc: Cod Notes: HACCP violations; 4/2023 Caviar de Riofrio S.L.U. Date Published : 04/17/2012 Riofrio, Loja , Camino de la Picifactoria 2
, Granada,
Andalucia SPAIN 16 Y - - 01 Caviar, Fishery Products, n.e.c.
Date Published: 04/17/2012

Desc: Caviar Gastraval S.L. Date Published : 04/09/2025 Poligono Industrial El Bony Calle 32 Numero 17
, Catarroja,
Valencia SPAIN 02 D - - 05 Rice Meal Processed (Packaged)
Date Published: 04/09/2025

Desc: Seafood Paella Notes: HACCP violations, 10/2024 02 D - - 99 Rice, Processed (Packaged) N.E.C.
Date Published: 04/09/2025

Desc: Seafood Paella Notes: HACCP violations, 10/2024 16 W - - 01 Meals separated in serving container with fish/fish products, Mixed Fishery/Seafood Products
Date Published: 04/09/2025

Desc: Seafood Paella Notes: HACCP violations, 10/2024 16 Y - - 99 Fishery Products, N.E.C.
Date Published: 04/09/2025

Desc: Seafood Paella Notes: HACCP violations, 10/2024 REAL CONSERVERA ESPANOLA, S.L. Date Published : 01/06/2026 Poligono Industrial Sete Pias No. 30 , Cambados
, Pontevedra,
Galicia SPAIN 16 A - - 22 Mackerel (only Scomberomorus spp eg. Spanish or King)
Date Published: 01/06/2026

Desc: Low acid canned Mackerel; Spanish or King Notes: A foreign inspection was conducted of this manufacturing facility and revealed serious deviations of the seafood HACCP regulation (21 CFR 123). Based on FDA?s inspectional findings, we have determined the listed products processed in the facility are adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (?Act?), in that they were prepared, packed or held under insanitary conditions whereby they may have been contaminated with filth or whereby they may have been rendered injurious to health. Specific violations include: 21 CFR 123.6(a) and (c)(1) ? Failure to conduct or have conducted for them a hazard analysis for each kind of fish and fishery product that they produce to determine whether there are food safety hazards that are reasonably likely to occur, and have a HACCP plan that, at a minimum, lists the food safety hazards that are reasonably likely to occur; 21 CFR 123.6(c)(3) ? Failure to have a HACCP plan that, at a minimum, lists the critical limits that must be met; 21 CFR 123.6(c)(4) - Failure to have a HACCP plan that, at a minimum, lists monitoring procedures and their frequency for each critical control point; and 21 CFR 123.7(b) - Failure to have appropriate corrective actions. 16 A - - 33 Sardines (Brisling, Sprats, Pilchards, Etc.)
Date Published: 01/06/2026

Desc: Low acid canned Sardines Notes: A foreign inspection was conducted of this manufacturing facility and revealed serious deviations of the seafood HACCP regulation (21 CFR 123). Based on FDA?s inspectional findings, we have determined the listed products processed in the facility are adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (?Act?), in that they were prepared, packed or held under insanitary conditions whereby they may have been contaminated with filth or whereby they may have been rendered injurious to health. Specific violations include: 21 CFR 123.6(a) and (c)(1) ? Failure to conduct or have conducted for them a hazard analysis for each kind of fish and fishery product that they produce to determine whether there are food safety hazards that are reasonably likely to occur, and have a HACCP plan that, at a minimum, lists the food safety hazards that are reasonably likely to occur; 21 CFR 123.6(c)(3) ? Failure to have a HACCP plan that, at a minimum, lists the critical limits that must be met; 21 CFR 123.6(c)(4) - Failure to have a HACCP plan that, at a minimum, lists monitoring procedures and their frequency for each critical control point; and 21 CFR 123.7(b) - Failure to have appropriate corrective actions. 16 A - - 73 Mackerel (all except Scomberomorus sp, eg Spanish or King see '22')
Date Published: 01/06/2026

Desc: Low acid canned Mackerel Notes: A foreign inspection was conducted of this manufacturing facility and revealed serious deviations of the seafood HACCP regulation (21 CFR 123). Based on FDA?s inspectional findings, we have determined the listed products processed in the facility are adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (?Act?), in that they were prepared, packed or held under insanitary conditions whereby they may have been contaminated with filth or whereby they may have been rendered injurious to health. Specific violations include: 21 CFR 123.6(a) and (c)(1) ? Failure to conduct or have conducted for them a hazard analysis for each kind of fish and fishery product that they produce to determine whether there are food safety hazards that are reasonably likely to occur, and have a HACCP plan that, at a minimum, lists the food safety hazards that are reasonably likely to occur; 21 CFR 123.6(c)(3) ? Failure to have a HACCP plan that, at a minimum, lists the critical limits that must be met; 21 CFR 123.6(c)(4) - Failure to have a HACCP plan that, at a minimum, lists monitoring procedures and their frequency for each critical control point; and 21 CFR 123.7(b) - Failure to have appropriate corrective actions. 16 A - - 99 Fish, N.E.C.
Date Published: 01/06/2026

Desc: Low acid canned Gar Notes: A foreign inspection was conducted of this manufacturing facility and revealed serious deviations of the seafood HACCP regulation (21 CFR 123). Based on FDA?s inspectional findings, we have determined the listed products processed in the facility are adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (?Act?), in that they were prepared, packed or held under insanitary conditions whereby they may have been contaminated with filth or whereby they may have been rendered injurious to health. Specific violations include: 21 CFR 123.6(a) and (c)(1) ? Failure to conduct or have conducted for them a hazard analysis for each kind of fish and fishery product that they produce to determine whether there are food safety hazards that are reasonably likely to occur, and have a HACCP plan that, at a minimum, lists the food safety hazards that are reasonably likely to occur; 21 CFR 123.6(c)(3) ? Failure to have a HACCP plan that, at a minimum, lists the critical limits that must be met; 21 CFR 123.6(c)(4) - Failure to have a HACCP plan that, at a minimum, lists monitoring procedures and their frequency for each critical control point; and 21 CFR 123.7(b) - Failure to have appropriate corrective actions. 16 S - - 33 Sardines (Brisling, Sprats, Pilchards, etc.), Cold Smoked, Fish
Date Published: 01/06/2026

Desc: Low acid canned Sardines; Cold Smoked Notes: A foreign inspection was conducted of this manufacturing facility and revealed serious deviations of the seafood HACCP regulation (21 CFR 123). Based on FDA?s inspectional findings, we have determined the listed products processed in the facility are adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (?Act?), in that they were prepared, packed or held under insanitary conditions whereby they may have been contaminated with filth or whereby they may have been rendered injurious to health. Specific violations include: 21 CFR 123.6(a) and (c)(1) ? Failure to conduct or have conducted for them a hazard analysis for each kind of fish and fishery product that they produce to determine whether there are food safety hazards that are reasonably likely to occur, and have a HACCP plan that, at a minimum, lists the food safety hazards that are reasonably likely to occur; 21 CFR 123.6(c)(3) ? Failure to have a HACCP plan that, at a minimum, lists the critical limits that must be met; 21 CFR 123.6(c)(4) - Failure to have a HACCP plan that, at a minimum, lists monitoring procedures and their frequency for each critical control point; and 21 CFR 123.7(b) - Failure to have appropriate corrective actions. Ricardo Fuentes E Hijos Salazon, S.A.U. Date Published : 11/03/2014 Avda/Tomas Ferro S-N , Poligano Industrial La Palma
, Cartagena,
Murcia SPAIN 16 A - - 45 Tuna (Albacore, Yellowfin, Bluefin, Skipjack, Etc.)
Date Published: 11/03/2014

Desc: Yellowfin Tuna; Dry-Cured; Vacuum Packaged (Mojama) Notes: Problem(s);
Firm ruled not in compliance with seafood HACCP as a result of a violative inspection 4/2014; and review of firm responses and supporting documentation. Salazones Garre, S.L. Date Published : 05/28/2020 Avenida Dr Artero Guirao 254
, San Pedro Del Pinatar,
Murcia SPAIN 16 A - - 45 Tuna (Albacore, Yellowfin, Bluefin, Skipjack, Etc.)
Date Published: 05/28/2020

Desc: Tuna Notes: HACCP Violations noted, July 2018

SRI LANKA

Foreconns Canneries Date Published : 11/27/2015 No. 548, Fullerton Industrial Zone
, Kalutara,
Kalutara SRI LANKA 16 - - - -- Fishery/Seafood Products
Date Published: 11/27/2015

Desc: All canned seafood products Pan-Am Foods (Pvt) Ltd. Date Published : 04/04/2014 F8-Seethawaka Industrial Park
, Avissawella,
Colombo SRI LANKA 16 - - - -- Fishery/Seafood Products
Date Published: 04/04/2014

Desc: All Seafood Products Notes: violation of the acidified food regulation; seafood Hazard Analysis and Critical Control Point regulation; and Current Good Manufacturing Practice regulation.

ST. VINCENT & THE GRENADINES

Blue Caribbean Foods Inc. Date Published : 07/01/2024 Kingstown Fish Market , Bay Street
, Kingstown,
Saint George ST. VINCENT & THE GRENADINES 16 A - - 45 Tuna (Albacore, Yellowfin, Bluefin, Skipjack, Etc.)
Date Published: 07/01/2024

Desc: Yellowtail Tuna Notes: HACCP violations, 11/13-14/2023 16 A - - 45 Tuna (Albacore, Yellowfin, Bluefin, Skipjack, Etc.)
Date Published: 07/01/2024

Desc: Big Eye Tuna Notes: HACCP violations, 11/13-14/2023

SURINAM

Suriname Sea Catch N.V. Date Published : 03/13/2009 Tennisbaan Straat 9
, Paramaribo,
SURINAM 16 A - C -- Fish, Raw, Fresh, Refrigerated
Date Published: 09/17/2021

Desc: Fresh-on-ice & fresh frozen scombrotoxin forming species Notes: 05/10/05 16 A - D -- Fish, Raw - Fresh, Frozen, Natural State
Date Published: 09/17/2021

Desc: Fresh-on-ice & fresh frozen scombrotoxin forming species Notes: 05/10/05 Unity N.V. (Surefish Industrial) Date Published : 03/13/2009 Industrial Invorno
, Paramaribo,
SURINAM 16 - - - -- Fishery/Seafood Products
Date Published: 03/13/2009

Desc: all histamine species Notes: 5/27/2005

SWITZERLAND

Balik, a branch of Caviar House & Prunier (Suisse) SA Date Published : 11/26/2019 Im Moos
, Ebersol-Mogelsberg,
Saint Gallen SWITZERLAND 16 S - - 32 Salmon (Humpback, Silver, King, Sockeye, etc.), Cold Smoked, Fish
Date Published: 11/26/2019

Desc: Vacuum packed cold-smoked salmon products Notes: Firm found to not be operating in compliance with seafood HACCP regulations 21 CFR 123.

TAIWAN

Taiwan Sing Rong Food Co.,LTD Date Published : 11/08/2018 No. 16, Chuan Chiang Lane, Chi Nan 1st , Rd., Chi Shan Dist., Kaohsiung City
, Kaohsiung City,
Kaohsiung - Special Municipali TAIWAN 15 Y - - 99 Egg And Egg Products Not Elsewhere Mentioned, N.E.C.
Date Published: 12/04/2018

Desc: Frozen Hot Pot Dumpling (Egg) Notes: Problem(s);
HAACCP Violations 16 W - - 99 Mixed Fishery/Seafood Products, N.E.C.
Date Published: 12/04/2018

Desc: Frozen Dumpling for Hot Pot (Cuttlefish; Shrimp) Notes: Problem(s);
HAACCP Violations 16 Y - - 03 Fish Paste, Fishery Products, n.e.c.
Date Published: 12/20/2018

Desc: Frozen Hot Pot (Fish) Dumplings w/fish paste and squid Notes: CFSAN states firm did not adequately address deviations observed in April 9; 2018 Warning Letter after inspection of firm.

THAILAND

Chonburi Lc Company Lilmited Date Published : 03/13/2009 44/6 M.1, T. Nhongmaidaeng
, Chonburi,
THAILAND 16 A - H 01 Anchovy, Ntrl/Artfcl Dried
Date Published: 03/13/2009

Notes: Dried anchovies

6/30/2006 Green Giant Co., Ltd. Date Published : 03/13/2009 19/7 Moo 15 Tapa , Leab Klong Cholpratan Rd
, Banpong,
Ratchaburi THAILAND 16 A - H 01 Anchovy, Ntrl/Artfcl Dried
Date Published: 03/13/2009

Notes: Dried anchovies

6/19/2006 Hong Shun Fishery Co., Ltd. Date Published : 03/13/2009 64/215 Moo 7 Ratsada
, Muang Phuket,
THAILAND 16 A - - 45 Tuna (Albacore, Yellowfin, Bluefin, Skipjack, Etc.)
Date Published: 03/13/2009

Notes: Frozen yellow fin tuna

6/19/2006 I-TAIL CORPORATION PUBLIC COMPANY LIMITED Limited Company Date Published : 12/14/2010 333 Moo 2, Kamjanavanich Road
, Mueang Songkhla,
Songkhla THAILAND 16 J - - 01 Crab
Date Published: 01/13/2011

Desc: Pasteurized crab meat Notes: DWPE date - 12/14/2010 P.t. Surya Terbit Co.,ltd. Date Published : 04/23/2010 2/100-101 Moo 1 , Srisutas Road , T . , Rassada, A. Muang , Phuket
, Phuket,
Th-83 THAILAND 16 A - - 45 Tuna (Albacore, Yellowfin, Bluefin, Skipjack, Etc.)
Date Published: 04/23/2010

Desc: Tuna S J SUPREME Date Published : 03/13/2009 30/76 SOI 49, RAMA 2 Rd. , BANGKHUNTIEN
, BANGKOK,
TH-NOTA THAILAND 16 A - - 01 Anchovy
Date Published: 03/13/2009

Notes: Crispy anchovy snacks

6/17/2008 16 B - - 01 Anchovy, Breaded
Date Published: 03/13/2009

Notes: Crispy anchovy snacks

6/17/2008 16 C - - 01 Anchovy, Cakes, Balls, Etc.
Date Published: 03/13/2009

Notes: Crispy anchovy snacks

6/17/2008 Saigon International (2004) Date Published : 03/13/2009 113 Moo 9 Paengpuey Sub-District , Damnernsaduak District
, Ratchaburi,
Th-70 THAILAND 16 Y - - 09 Fish Sauce, Fishery Products, n.e.c.
Date Published: 03/13/2009

Notes: Fermented anchovy sauce

4/25/2008 Sakhon Wattana (Thang Chue Hah) Date Published : 10/30/2024 10 Khor, Thammakunakorn Rd., Krokkrak
, Mueang Samut Sakhon,
Samut Sakhon THAILAND 16 Y - - 09 Fish Sauce, Fishery Products, n.e.c.
Date Published: 10/30/2024

Desc: Fish Sauce Notes: HACCP violations, 2/2024 Tang Thai Chiang Fish Sauce Manufacturing Co.,Ltd. Date Published : 04/09/2019 25 Aree-Ras Road, Paknum
, Muang,
Rayong THAILAND 16 Y - - 04 Fish Roe, Fishery Products, n.e.c.
Date Published: 04/09/2019

Desc: Fish Sauce Notes: Violations of Seafood HACCP regulation; 21 CFR 123. 16 Y - - 09 Fish Sauce, Fishery Products, n.e.c.
Date Published: 04/09/2019

Desc: Fish Sauce Notes: Violations of Seafood HACCP regulation; 21 CFR 123. 16 Y - - 11 Shrimp Sauce, Fishery Products, n.e.c.
Date Published: 04/09/2019

Desc: Shrimp paste Notes: Violations of Seafood HACCP regulation; 21 CFR 123. 16 Y - - 12 Shrimp Paste, Fishery Products, n.e.c.
Date Published: 04/09/2019

Desc: Shrimp paste Notes: Violations of Seafood HACCP regulation; 21 CFR 123. Thang Nguan Hah Co.,Ltd. Date Published : 04/21/2014 92 , Moo 1; Wat Pradoo
, Amphawa,
Samut Songkhram THAILAND 16 Y - - 07 Fish Maw, Fishery Products, n.e.c.
Date Published: 04/21/2014

Desc: Fish Sauce; Anchovy Fish Sauce 16 Y - - 09 Fish Sauce, Fishery Products, n.e.c.
Date Published: 04/21/2014

Desc: Fish Sauce; Anchovy Fish Sauce 16 Y - - 99 Fishery Products, N.E.C.
Date Published: 04/21/2014

Desc: Fish Sauce; Anchovy Fish Sauce UE CHOON LEE CO.,LTD Date Published : 03/04/2019 Bangpakok, Ratburana, Bangkok.
, Rat Burana,
Bangkok THAILAND 16 Y - - 12 Shrimp Paste, Fishery Products, n.e.c.
Date Published: 03/04/2019

Desc: Shrimp Paste Products Notes: Problem; Seafood HACCP Violations

TRINIDAD & TOBAGO

Oceanside Fish Center Ltd. Date Published : 09/16/2009 191 Western Main Rd. Carenage
, Pt Cumana,
TT-DMN TRINIDAD & TOBAGO 16 A - - 45 Tuna (Albacore, Yellowfin, Bluefin, Skipjack, Etc.)
Date Published: 09/16/2009

Notes: 1/9/2009 Silva Hook Exports Date Published : 09/16/2009 Production Avenue
, Port-of-Spain,
TRINIDAD & TOBAGO 16 A - - 45 Tuna (Albacore, Yellowfin, Bluefin, Skipjack, Etc.)
Date Published: 09/16/2009

Notes: 1/9/2009

TURKEY

Kemal Balikcilik Ihracat Date Published : 03/14/2022 Icmeler Mahallesi , Cesme Urla Izmir Asfalti Caddesi No 329
, Urla,
Izmir TURKEY 16 A - - 01 Anchovy
Date Published: 03/14/2022

Desc: Anchovy Notes: HACCP Violations noted January 2022 16 A - - 04 Bass, Salt or Brackisk Water (Stripe Bass, white Perch, Black Bass, Etc.)
Date Published: 03/14/2022

Desc: Seabass Notes: HACCP Violations noted January 2022 16 A - - 32 Salmon (Humpback, Silver, King, Sockeye, Etc.)
Date Published: 03/14/2022

Desc: Salmon Notes: HACCP Violations noted January 2022 16 A - - 44 Trout (Rainbow, Brook, Brown, Char, Steelhead, Etc.)
Date Published: 03/14/2022

Desc: Trout Notes: HACCP Violations noted January 2022 16 A - - 45 Tuna (Albacore, Yellowfin, Bluefin, Skipjack, Etc.)
Date Published: 03/14/2022

Desc: Tuna Notes: HACCP Violations noted January 2022 16 A - - 80 Bream
Date Published: 03/14/2022

Desc: Seabream Notes: HACCP Violations noted January 2022 16 A - - 85 Barramundi
Date Published: 03/14/2022

Desc: Seabass Notes: HACCP Violations noted January 2022 16 X - - 01 Bass, hybrid striped, Aquaculture Harvested Fishery/Seafood Products
Date Published: 03/14/2022

Desc: Seabass Notes: HACCP Violations noted January 2022 16 X - - 99 Aquaculture Harvested Fishery/Seafood Products, N.E.C.,
Date Published: 03/14/2022

Desc: Seabream Notes: HACCP Violations noted January 2022

UKRAINE

TOV "Universal Fish Company" Date Published : 11/30/2017 Svativska Street 55
, Kupyansk,
Kharkivska Oblast UKRAINE 16 A - - 21 Herring
Date Published: 11/30/2017

Desc: Brined Ready-to-Eat Herring Notes: Problem(s):
HACCP Violations 16 A - - 21 Herring
Date Published: 11/30/2017

Desc: Herring in Oil Notes: Problem(s):
HACCP Violations 16 A - - 21 Herring
Date Published: 11/30/2017

Desc: Herring in Oil 5 Peppers Notes: Problem(s):
HACCP Violations 16 A - - 21 Herring
Date Published: 11/30/2017

Desc: Herring Fillets in Oil Notes: Problem(s):
HACCP Violations Universal Fish Company Date Published : 11/30/2017 Golovatogo str 83
, Borispol,
Kyivska Oblast UKRAINE 16 A - - 21 Herring
Date Published: 11/30/2017

Desc: Herring Fillets in Oil Notes: Problem(s):
HACCP Violations 16 A - - 21 Herring
Date Published: 11/30/2017

Desc: Herring in Oil Notes: Problem(s):
HACCP Violations 16 A - - 21 Herring
Date Published: 11/30/2017

Desc: Brined Ready-to-Eat Herring Notes: Problem(s):
HACCP Violations 16 A - - 21 Herring
Date Published: 11/30/2017

Desc: Herring in Oil 5 Peppers Notes: Problem(s);
HACCP Violations

VENEZUELA

Alimentos Tesoro Azul S.A. Date Published : 09/24/2025 Ave. 1a Con Calle 1-A1, #1a 1-259
, La Concepcion,
Zulia VENEZUELA 16 J - - 01 Crab
Date Published: 09/24/2025

Desc: Crab Meat Notes: Based on FDA?s recent FRRA findings, the previous FRRA, and the firm?s inadequate response to findings, the firm?s ready-to-eat cooked crab meat products appear to be adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. ? 342(a)(4)]. Specific violations include: 123.6(c)(1) ? HACCP Plan shall list food safety hazards that are reasonably likely to occur; 123.6(c)(2) ? list critical control points for each of the identified food safety hazards; 123.6(c)(3) ? list the critical limit that must be met at each of the critical control points. Corporacion Del Mar C.A. Date Published : 12/13/2011 Av. San Francisco No. 51-315 , Sector El Bajo
, Maracaibo,
VE-V VENEZUELA 16 J - - 01 Crab
Date Published: 12/13/2011

Desc: Crabmeat FACTORIA DEL LAGO C.A. Date Published : 01/18/2011 Edif. Villa Ota Ii, 3er Piso,Offic. , Calle 76 Entre Av 3h y 3y Sector a Lago3
, Maracaibo,
Zulia VENEZUELA 16 J - - 01 Crab
Date Published: 01/18/2011

Desc: Crab Meat Fresco Mar C.A. Date Published : 03/13/2009 De Pozo, Peninsula de Macarao , Calle Ortiz,Sector Champoturo, Boca
, Margarita,
VENEZUELA 16 J - D 05 Shrimp & Prawns, Raw - Fresh, Frozen, Natural State
Date Published: 09/07/2021

Desc: Shrimp frozen raw Notes: 12/31/2002 16 X - D 21 Shrimp and prawns, Aquaculture Harvested Fishery/Seafood Products, Raw - Fresh, Frozen, Natural State
Date Published: 09/07/2021

Desc: Shrimp frozen raw Notes: 12/31/2002 Grupo VPAS C.A. Date Published : 09/10/2025 Urb. Los Ruices Sur , Trieste Local Galpon S/N
, Caracas,
Miranda VENEZUELA 16 A - - 37 Snapper (Red, Gray, Malabar, etc.)
Date Published: 09/10/2025

Desc: IQF Medregal fillet with skin and without skin; Medregal; Seriola dumerili; Greater Amberjack; Yellowtail Notes: Medregal, Seriola dumerili, is known as Greater Amberjack, Yellowtail.

Problem(s): FDA conducted a Foreign Remote Regulatory Assessment, of this food manufacturing facility and found serious deviations of the Seafood HACCP regulations (21 CFR Part 123). On October 17, 2024, the firm was issued an FDA Warning Letter. Based on FDA?s inspectional findings and review of the firm responses, we have determined the listed seafood products processed in the facility appear adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. ?342(a)(4)]. Specific violations include: 21 CFR 123.6(c)(3) ? The critical limits are either not listed in the plan or are inadequate; 123.6(c)(2) ? Critical control points are not listed in the HACCP plan; 21 CFR 123.6(c)(4) ? Monitoring procedures are either not listed or inadequate. 16 A - - 79 Yellowtail, Amberjack
Date Published: 09/10/2025

Desc: IQF Medregal fillet with skin and without skin; Medregal; Seriola dumerili; Greater Amberjack; Yellowtail Notes: Medregal, Seriola dumerili, is known as Greater Amberjack, Yellowtail.

Problem(s): FDA conducted a Foreign Remote Regulatory Assessment, of this food manufacturing facility and found serious deviations of the Seafood HACCP regulations (21 CFR Part 123). On October 17, 2024, the firm was issued an FDA Warning Letter. Based on FDA?s inspectional findings and review of the firm responses, we have determined the listed seafood products processed in the facility appear adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. ?342(a)(4)]. Specific violations include: 21 CFR 123.6(c)(3) ? The critical limits are either not listed in the plan or are inadequate; 123.6(c)(2) ? Critical control points are not listed in the HACCP plan; 21 CFR 123.6(c)(4) ? Monitoring procedures are either not listed or inadequate. 16 - - - -- Fishery/Seafood Products
Date Published: 09/10/2025

Desc: IQF Medregal fillet with skin and without skin; Medregal; Seriola dumerili; Greater Amberjack; Yellowtail Notes: Medregal, Seriola dumerili, is known as Greater Amberjack, Yellowtail.

Problem(s): FDA conducted a Foreign Remote Regulatory Assessment, of this food manufacturing facility and found serious deviations of the Seafood HACCP regulations (21 CFR Part 123). On October 17, 2024, the firm was issued an FDA Warning Letter. Based on FDA?s inspectional findings and review of the firm responses, we have determined the listed seafood products processed in the facility appear adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. ?342(a)(4)]. Specific violations include: 21 CFR 123.6(c)(3) ? The critical limits are either not listed in the plan or are inadequate; 123.6(c)(2) ? Critical control points are not listed in the HACCP plan; 21 CFR 123.6(c)(4) ? Monitoring procedures are either not listed or inadequate. PESCAMARCA PESCADORES MARINOS C.A. Date Published : 01/18/2011 CASA S/N, AV #01 PALMAREJO NUEVO
, La canada de urdaneta,
VE-V VENEZUELA 16 J - - 05 Shrimp & Prawns
Date Published: 01/18/2011

Desc: shrimp 16 X - - 21 Shrimp and prawns, Aquaculture Harvested Fishery/Seafood Products
Date Published: 01/18/2011

Desc: shrimp PROCESADORA "EL CANGREJITO DEL MAR" C.A. (PROCAMAR, C.A.) Date Published : 05/11/2012 Avenida Principal De La Guajira
, Concepcion,
Zulia VENEZUELA 16 J - - 01 Crab
Date Published: 05/11/2012

Desc: Crabmeat Procesadora Marina De La Costa Oriental Del Lago C.A. Date Published : 12/06/2024 Calle Rafael Urdaneta Casa Nro S/N Sector Punta Iguana Sur
, Santa Rita,
Zulia VENEZUELA 16 J - - 01 Crab
Date Published: 12/06/2024

Desc: Ready-To-Eat (RTE) cooked refrigerated and frozen crab meat Notes: HACCP violations; 05/17/2024

VIETNAM

BaRia-VungTau Seafood Processing & Import- Export J.S.C. Date Published : 12/15/2015 Ba Ria Townlet, Br-Vt Province , 51, National Road, Phuoc Trung Ward
, S.R. Vietnam,
Br-Vt VIETNAM 16 - - H -- Fishery/Seafood Products, Ntrl/Artfcl Dried
Date Published: 12/15/2015

Desc: Dried fish products Notes: CFSAN recommends the firm to be added to Import Alert #16-120 for significant deviations from the Seafood HACCP regulation; 21 CFR 123. On September 30; 2015; the firm?s response to a violative inspection conducted on June 1-2; 2015; included revised HACCP plans. The HACCP plans were reviewed and found to be inadequate as further explained in the 12/03/2015 issued detention letter. Binh Dinh Fishery Joint Stock Company Date Published : 04/11/2012 02D Tran Hung Dao Street
, Quy Nhon,
Binh Dinh VIETNAM 16 A - - 45 Tuna (Albacore, Yellowfin, Bluefin, Skipjack, Etc.)
Date Published: 04/11/2012

Desc: Tuna 16 A - - 51 Mahi Mahi
Date Published: 04/11/2012

Desc: Mahi Mahi Hung Loi Manufacturing and Trading Co. Ltd. Date Published : 09/01/2014 H37 Road No. 01 , Le Minh Xuan Industrial Zone
, Ho Chi Minh City,
Binh Chanh District VIETNAM 16 A - - 01 Anchovy
Date Published: 09/01/2014

Desc: Preserved ground anchovy fish in brine Notes: Violative Inspection; Hazards of Pathogenic Bacteria Growth; Toxin Formation; Undeclared Allergens 16 A - - 22 Mackerel (only Scomberomorus spp eg. Spanish or King)
Date Published: 09/01/2014

Desc: Salted mackerel in soya bean oil Notes: Violative Inspection; Hazards of Pathogenic Bacteria Growth; Toxin Formation; Undeclared Allergens 16 A - - 52 Gourmay, gourami
Date Published: 09/01/2014

Desc: Preserved ground gourami fish in brine Notes: Violative Inspection; Hazards of Pathogenic Bacteria Growth; Toxin Formation; Undeclared Allergens 16 A - - 52 Gourmay, gourami
Date Published: 09/01/2014

Desc: Preserved boneless gourami fish in brine Notes: Violative Inspection; Hazards of Pathogenic Bacteria Growth; Toxin Formation; Undeclared Allergens 16 A - - 60 Sheatfish
Date Published: 09/01/2014

Desc: Salted sheatfish in brine Notes: Violative Inspection; Hazards of Pathogenic Bacteria Growth; Toxin Formation; Undeclared Allergens 16 A - - 62 Snake Head
Date Published: 09/01/2014

Desc: Reduced oxygen packaged non-refrigerated salted snakehead fish in brine Notes: Violative Inspection; Hazards of Pathogenic Bacteria Growth; Toxin Formation; Undeclared Allergens 16 A - - 62 Snake Head
Date Published: 09/01/2014

Desc: Preserved whole snakehead in brine Notes: Violative Inspection; Hazards of Pathogenic Bacteria Growth; Toxin Formation; Undeclared Allergens 16 A - - 62 Snake Head
Date Published: 09/01/2014

Desc: Preserved ground snakehead fish in brine Notes: Violative Inspection; Hazards of Pathogenic Bacteria Growth; Toxin Formation; Undeclared Allergens 16 A - - 62 Snake Head
Date Published: 09/01/2014

Desc: Preserved boneless snakehead fish in brine Notes: Violative Inspection; Hazards of Pathogenic Bacteria Growth; Toxin Formation; Undeclared Allergens 16 A - - 73 Mackerel (all except Scomberomorus sp, eg Spanish or King see '22')
Date Published: 09/01/2014

Desc: Salted mackerel in soya bean oil Notes: Violative Inspection; Hazards of Pathogenic Bacteria Growth; Toxin Formation; Undeclared Allergens; 16 A - - 99 Fish, N.E.C.
Date Published: 09/01/2014

Desc: Preserved dorab fish in brine Notes: Violative Inspection; Hazards of Pathogenic Bacteria Growth; Toxin Formation; Undeclared Allergens NHAT NGUYEN FOODS COMPANY LIMITED Date Published : 03/13/2009 1a National Road, Cam Thinh Dong
, Cam Ranh,
Khanh Hoa VIETNAM 16 A - H 01 Anchovy, Ntrl/Artfcl Dried
Date Published: 03/13/2009

Notes: Dried anchovy

12/16/2005 Nam Hai Company Ltd. Date Published : 03/13/2009 An Lac Ward, Binh Tan District , 555, Kinh Duong Vuong St.
, Ho Chi Minh City,
Ho Chi Minh City VIETNAM 16 A - - 73 Mackerel (all except Scomberomorus sp, eg Spanish or King see '22')
Date Published: 03/13/2009

Notes: Steamed mackeral

10/16/2003 Nam Long Seafood Export Processing Factory Date Published : 10/12/2017 Tranthoi Village , Cai Nuoc District
, Ca Mau Province,
VIETNAM 16 J - - 05 Shrimp & Prawns
Date Published: 10/12/2017

Desc: Cooked Shrimp Notes: Problem(s);HACCP violations 16 X - - 21 Shrimp and prawns, Aquaculture Harvested Fishery/Seafood Products
Date Published: 10/12/2017

Desc: Cooked Shrimp Notes: Problem(s); HACCP violations Nature Health NHC Limited Liability Company Date Published : 05/08/2025 59/5e, Tien Lan 13a, Tien Lan 1 Hamlet, Ba Diem Commue, Hoc Mon District
, Ho Chi Minh City,
VIETNAM 16 A - - 26 Perch, Fresh Water (Yellow, Lake)
Date Published: 05/08/2025

Desc: Braised Climbing Perch with Coconut Juice Ca Ro Kho nuoc dua Notes: HACCP violations, 10/2024 The firm has not identified the overnight refrigerated storage of its cooked perch product as a critical control point that ensures the products are continuously kept at or below 4.4C (40F) to control for the food safety hazard of pathogen growth and toxin formation. The monitoring procedure to check that finished product labels contain a ?keep frozen? statement at the ?Receiving Labels? critical control point would be more appropriately included at the firm?s ?Finished Product Labeling? critical control point to ensure that finished products are properly labeled rather than simply relying on incoming labels to be properly printed. Thanh Ha Fish Sauce Co. Date Published : 01/12/2018 KP5- Duong Dong Town
, Phu Quoc Island,
Kien Giang Province VIETNAM 16 Y - - 09 Fish Sauce, Fishery Products, n.e.c.
Date Published: 01/12/2018

Desc: Fish Sauce Notes: Problem(s);HACCP Violations 16 Y - - 17 Sauce, seafood (n.e.c.), Fishery Products, n.e.c.
Date Published: 01/12/2018

Desc: Fish Sauce Notes: Problem(s);
HACCP Violations Truong Phu Xanh Co., Date Published : 11/29/2019 Lot 12 , Quang Phu Industrial Zone
, Quang Ngai,
VIETNAM 16 A - - 45 Tuna (Albacore, Yellowfin, Bluefin, Skipjack, Etc.)
Date Published: 11/29/2019

Desc: Yellowfin Tuna Products Notes: Firm found to not be operating in compliance with seafood HACCP regulations 21 CFR 123. Vung Tau Catching Fishery And Service Corporation Date Published : 03/13/2009 191 Nguyen Thai Hoc Street, Dist. 01
, Ho Chi Minh City,
VIETNAM 16 A - - 56 Filefish
Date Published: 03/13/2009

Notes: Cream fish (Meuschenia scaber) aka Triggerfish

7/14/2005 16 A - - 65 Puffer
Date Published: 03/13/2009

Notes: Cream fish (Meuschenia scaber) aka Triggerfish

7/14/2005 16 A - - 73 Mackerel (all except Scomberomorus sp, eg Spanish or King see '22')
Date Published: 03/13/2009

Notes: Frozen mackeral

7/14/2005 16 E - - 02 Clams
Date Published: 03/13/2009

Notes: Cooked clam

7/14/2005 16 S - - 22 Mackerel, Cold Smoked, Fish (only Scomberomorus spp eg. Spanish or King)
Date Published: 03/13/2009

Notes: Frozen mackeral

7/14/2005

WESTERN SAMOA

APIA EXPORT FISH PACKERS LTD Date Published : 07/06/2020 Fisheries Wharf Savalalo
, Apia,
WESTERN SAMOA 16 A - - 45 Tuna (Albacore, Yellowfin, Bluefin, Skipjack, Etc.)
Date Published: 07/06/2020

Desc: Tuna Notes: HACCP Violations noted January 2020 16 A - - 51 Mahi Mahi
Date Published: 07/06/2020

Desc: Mahi-Mahi Notes: HACCP Violations noted January 2020 16 A - - 78 Wahoo
Date Published: 07/06/2020

Desc: Wahoo Notes: HACCP Violations noted January 2020 16 A - - -- Fish
Date Published: 07/06/2020

Desc: All Scombroid-species fin-fish Notes: HACCP Violations noted January 2020

Source

Analysis generated by AI. Source diff and links are from the original.

Classification

Agency
Food and Drug Administration
Published
January 14th, 2026
Instrument
Guidance
Legal weight
Non-binding
Stage
Final
Change scope
Substantive

Who this affects

Applies to
Food manufacturers Importers and exporters
Geographic scope
National (US)

Taxonomy

Primary area
Food Safety
Operational domain
Compliance
Topics
Seafood HACCP Import Compliance

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