FDA Warning Letter to El Rey USA Meats & Seafood Inc.

Delivery Method: VIA EMAIL AND UNITED PARCEL SERVICE Product: Food & Beverages Recipient: Recipient Name Mr. Daniel Leon Sr. Recipient Title CEO El Rey USA Meats & Seafood Inc. 2101 W. 74th St
Chicago, IL 60636-3652
United States

Issuing Office: Office of Inspections and Investigations United States

February 19, 2026

WARNING LETTER

Re: CMS# 722157

Dear Mr. Daniel Leon Sr.,

We inspected your seafood importer establishment, located at 2101 W. 74th St. Chicago, IL., 60636-3652 on January 5, 2026, through January 9, 2026. We conducted a previous inspection on November 15, 2022, through November 17, 2022, which resulted in your firm receiving a letter from FDA dated January 23, 2023, that explained your firm’s non-compliance with the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations Part 123 (21 CFR Part 123). This current follow-up inspection found that your firm still has serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations, Part 123 (21 CFR Part 123). The specific requirements for imported fish and fishery products are set out in 21 CFR 123.12.

As an importer of fish or fishery products, you must operate in accordance with the requirements of Part 123. In accordance with 21 CFR 123.12(d), there must be evidence that all fish and fishery products offered for entry into the United States have been processed under conditions that comply with 21 CFR Part 123. If assurances do not exist that the imported fish or fishery product has been processed under conditions that are equivalent to those required of domestic processors under 21 CFR Part 123, the fish or fishery products will appear to be adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 342(a)(4) and will be denied entry.

Because our inspection identified serious violations for 21 CFR Part 123, your Tilapia imported from (b)(4); Frozen Shrimp imported from (b)(4) and Frozen Shrimp Hoso imported from (b)(4) are adulterated under Section 402(a)(4) of the Act (21 U.S.C. § 342(a)(4)), in that they have been prepared, packed, or held under insanitary conditions whereby they may have been rendered injurious to health.

You may find the Act, the seafood HACCP regulation and the Fish and Fisheries Products Hazards & Controls Guidance through links in FDA's home page at www.fda.gov.

Your significant violations were as follows as noted on the FDA 483 dated 01/09/2026:

You do not have or have not implemented written verification procedures and an affirmative step for ensuring that fish and fishery products you import are processed in compliance with the Seafood HACCP regulation.

This is a repeat observation from the previous inspection that concluded on 11/17/2022.

Specifically, your written verification procedures ("El Rey USA Meats & Seafood Preventive Controls Plan" and "El Rey USA Meats & Seafood Food Safety Plan Receive to Dispatch") do not ensure that the following imported products were processed under conditions equivalent to U.S. HACCP requirements 21 CFR 123.12 (a) (2):

Shrimp from (b)(4)

Shrimp from (b)(4)

Frozen Tilapia from (b)(4)

The documents lack written specifications designed to ensure that imported shrimp and tilapia are not adulterated under Section 402 of the Federal Food, Drug, and Cosmetic Act.

Your written verification procedures do not identify which affirmation step(s) you have chosen to implement.

The document "El Rey USA Meats & Seafood Food Safety Plan Receive to Dispatch" was not signed and dated at the time of the activity, as required.

This letter may not list all the violations at your facility. You are responsible for ensuring that your seafood importer establishment operates in compliance with the Act and the seafood HACCP regulation (21 CFR Part 123). You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations for the fish or fishery products that you import into the United States.

We acknowledge your response to these 483 violations, that was sent to us via email by Maria De La Luz, Operation Manager dated 01/23/2026. The response consisted of acknowledgment of the violations noted during our inspection that concluded on 01/09/2026 and a statement that you will be complying; however, this response has been deemed inadequate. On 01/30/2026, we provided Maria D. De la Luz, Operation Manager with an email explaining why this response was inadequate and as of the date of this letter, we have not received any additional information to address the inadequacies.

You should respond in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific things you are doing to correct these violations. You should include in your response documentation, such as HACCP and importer verification records and records that document the performance and results of your firm’s affirmative steps, or other useful information that would assist us in evaluating your corrections. If you cannot complete all corrections before you respond, you should explain the reason for your delay and state when you will correct any remaining violations.

We may take further action if you do not promptly correct these violations. For instance, we may take further action to refuse admission of your imported fish or fishery products under Section 801(a) of the Act (21 U.S.C. § 381(a)), including placing your firm and the seafood products you import under "Detention Without Physical Examination," seize your product(s) and/or enjoin your firm from further violating the Act.

Please send your reply or if you have any questions regarding this letter via email to the Food and Drug Administration, Attention: Julie Scoma, Compliance Officer, julie.scoma@fda.hhs.gov, please reference CMS #722157 on any documents or records you provide and/or within the subject line of the email.

Sincerely,
/S/

Keith Jasukaitis
Program Division Director
300 River Place, Suite 5900
Detroit, MI 48207-4291

• ## Content current as of:

03/10/2026

• Regulated Product(s)

  • Food & Beverages