FDA Warning Letters

Exactech Inc. Receives FDA Warning Letter for Quality System Violations at Sarasota Facility

FDA issued a Warning Letter (CMS # 720250) to Exactech Inc. dba Advita Ortho on December 19, 2025, citing seven Quality System Regulation violations discovered during a July 15–25, 2025 inspection of the firm's Sarasota, Florida facility. The violations include process control deficiencies, inadequate corrective and preventive action (CAPA) procedures, nonconforming product control failures, environmental control deficiencies, supplier quality management failures, training documentation gaps, and acceptance activity procedure deficiencies. The firm manufactures the Equinoxe Reverse Shoulder Compression Screw and related Equinoxe Reverse Shoulder System accessories. FDA has determined these devices are adulterated under section 501(h) of the Federal Food, Drug, and Cosmetic Act. Exactech must respond in writing within fifteen business days of receipt.

FDA Warning Letter to Tentamus India Private Limited for CGMP Violations

FDA inspected Tentamus India Private Limited, a contract testing laboratory in Hyderabad, India (FEI 3010960741), from August 14-22, 2025, and found the firm's drug products are adulterated under sections 501(a)(2)(B) and 501(j) of the FD&C Act due to CGMP violations and obstruction of inspection. The violations include: quality control unit failures (torn analytical records found in garbage bags, unofficial personal diaries used for CGMP documentation); inadequate investigation of out-of-specification results (reissued test reports without supporting documentation); non-contemporaneous documentation (pre-signed blank maintenance forms, backdated spectrometry records); and limiting access to records during inspection. FDA requires a comprehensive response within 15 working days detailing corrective actions, risk assessments, and CAPA implementation.

FDA Warning Letter to Simtra BioPharma Solutions for CGMP Violations at German Sterile Drug Facility

FDA issued Warning Letter 320-26-49 to Simtra BioPharma Solutions on March 3, 2026, following an unannounced inspection of its Simtra Deutschland GmbH sterile drug manufacturing facility in Halle/Westphalia, Germany from September 18-26, 2025. The agency cited significant CGMP violations including contaminated water systems with deadlegs causing 47 microbial recoveries (14 exceeding action limits), failed glove integrity testing used for production over an 18-day period, and inadequate vaporized hydrogen peroxide sterilization validation cycles with repeated biological indicator recoveries in nearly all validation runs. FDA requires a comprehensive written response within 15 working days detailing corrective actions.

FDA Warns UK Online Retailer for Selling Nicotine Pouches to Minor in Violation of Federal Tobacco Law

The FDA Center for Tobacco Products issued a warning letter to snushaven.com, a UK-based online tobacco retailer, for selling Zyn Apple Mint Mini (6mg) nicotine pouch products to a person younger than 21 years of age through its website. The product is deemed misbranded under Section 903(a)(7)(B) of the Federal Food, Drug, and Cosmetic Act because it was sold to a minor in violation of the federal minimum-age-of-sale requirement. The FDA has requested a written response within 15 working days describing corrective actions and compliance plans, and warns that continued violations may result in civil money penalties, seizure, and/or injunction.

FDA Warning Letter to SSS AUSTAR LLC for Unauthorised Nicotine Pouch Sales

The FDA Center for Tobacco Products issued a Warning Letter to SSS AUSTAR LLC, an Austin, Texas company, for selling and distributing ZIMO MINT 6MG nicotine pouch products without required premarket authorization. FDA determined the product is adulterated under FD&C Act Section 902(6)(A) and misbranded under Section 903(a)(6). The company has 15 working days from receipt to submit a written response describing corrective actions and plans for maintaining compliance with the FD&C Act.

FDA Warning Letter to El Rey USA Meats & Seafood Inc. - Repeat Seafood HACCP Violations

The FDA inspected El Rey USA Meats & Seafood Inc., a seafood importer in Chicago, IL, from January 5–9, 2026 and found the firm still non-compliant with the seafood HACCP regulation (21 CFR Part 123) despite a prior warning letter issued January 23, 2023 following a November 2022 inspection. The firm's Tilapia, Frozen Shrimp, and Frozen Shrimp Hoso imported from multiple countries were deemed adulterated under Section 402(a)(4) of the FD&C Act. FDA rejected the firm's January 23, 2026 response as inadequate and demands written corrective actions within fifteen working days, warning of possible refusal of admission, detention without physical examination, seizure, and injunction.

FDA Warns idripejuice.com for Selling GiMi 8500 ENDS to Minor

The FDA Center for Tobacco Products determined that idripejuice.com sold GiMi 8500 Disposable 5% Pineapple Breeze ENDS products to a person under 21 years of age, rendering the products misbranded under section 903(a)(7)(B) of the FD&C Act. The retailer must submit a written response within 15 working days describing corrective actions and compliance plans or face civil money penalties, seizure, and/or injunction.

FDA Warning Letter to Peaks Curative for False Semaglutide Claims

The FDA issued a Warning Letter to Peaks Curative, LLC (dba Peaks) on February 20, 2026, for offering compounded semaglutide products on its website (peakscurative.com) with false or misleading claims in violation of sections 502(a) and 502(bb) of the Federal Food, Drug, and Cosmetic Act (FDCA). The agency found that the website falsely identified "Peak Now" as the compounder when it is not, and made claims implying FDA-approval for compounded drug products that are not approved. The letter puts the company on notice and requests a written response within fifteen (15) working days describing specific corrective steps.

FDA Warning Letter to Good Girl LLC for Misbranded Compounded Semaglutide and Tirzepatide Products

The FDA issued a Warning Letter to Good Girl LLC (dba GoodGirlRX) on February 20, 2026, citing violations of the Federal Food, Drug, and Cosmetic Act for marketing misbranded compounded semaglutide and tirzepatide products. The company's website made false or misleading claims, including representing products as 'FDA-approved' when compounded drugs are not FDA-approved, and falsely suggesting GoodGirlRX was the compounder when it is not. The FDA requires a written response within fifteen (15) working days detailing specific corrective steps. Failure to adequately address violations may result in legal action including seizure and injunction without further notice.

FDA Warning Letter to Lean Rx Inc. dba SkinnyRx for Misbranded Compounded Semaglutide and Tirzepatide Products

The FDA's Center for Drug Evaluation and Research issued a Warning Letter on February 20, 2026 to Lean Rx Inc. dba SkinnyRx (Sacramento, CA) citing misbranded compounded semaglutide and tirzepatide products offered on the company's website. Violations include false or misleading labeling under sections 502(a) and 502(bb) of the FDCA [21 U.S.C. §§ 352(a) and 352(bb)]—specifically, the website displayed 'SkinnyRx' on product labels implying they were the compounder when they are not, and claims implying FDA-approval for products that are not approved. The company has 15 working days to respond with specific corrective steps or face legal action including seizure and injunction.

FDA Warning Letter to Ivim Services LLC for Misbranded Compounded Semaglutide and Tirzepatide

FDA's Center for Drug Evaluation and Research issued a Warning Letter to Ivim Services LLC dba Ivim on February 20, 2026, for misbranded compounded semaglutide and tirzepatide drug products. The violation stems from the company's website displaying these products with Ivim identified on the label as the compounder, when Ivim is not actually the manufacturer. FDA determined this violates sections 502(a) and 502(bb) of the FDCA. Ivim has 15 working days from receipt to provide a written response describing corrective steps taken.

FDA Warns PharmaZee for False Semaglutide and Tirzepatide Claims

The FDA's Center for Drug Evaluation and Research (CDER) issued a Warning Letter to PharmaZee LLC (5940 S Rainbow Blvd, Las Vegas, NV) on February 20, 2026, for false or misleading claims on its website regarding compounded semaglutide and tirzepatide products. The agency found that PharmaZee's website misrepresented the company as the compounder of these drugs when it is not, and made claims including 'clinically proven medications' and 'proven prescription medications' that are false because compounded drugs are not FDA-approved. The company must respond within 15 working days with corrective actions or face legal action including seizure and injunction.

FDA Warns Refills Health for Misbranded Compounded Semaglutide Claims

FDA's Center for Drug Evaluation and Research issued a Warning Letter to Refills Health, LLC on February 20, 2026, for offering compounded semaglutide products with false or misleading claims on its website at https://www.refills.com. The agency found that Refills Health misrepresented itself as the compounder of the drugs when it is not, and made unsupported claims including "clinically proven" and references to FDA-approved treatments for products that are neither approved nor evaluated by FDA. The company has 15 working days to respond with specific corrective steps.

FDA Warns Premium Health for Misbranded Semaglutide and Tirzepatide Products

The FDA issued a Warning Letter to Premium Health Management Inc. dba Premium Health on February 20, 2026, for marketing compounded semaglutide and tirzepatide drug products that are misbranded under sections 502(a) and 502(bb) of the Federal Food, Drug, and Cosmetic Act. The website falsely represented that Premium Health is the compounder of these products when it is not, and made misleading claims implying FDA approval for products that are not approved. The FDA requires a written response within fifteen (15) working days describing corrective steps or warns of legal action including seizure and injunction.

FDA Warns Las Americas Supermercado#2 Inc. Over FSVP Violations

The FDA's Division of Southwest Imports issued a warning letter to Las Americas Supermercado#2 Inc. (Tulsa, OK) on September 24, 2025, for violations of the Foreign Supplier Verification Program (FSVP) regulation discovered during inspections conducted August 28–September 8, 2025, and June 9–23, 2021. The firm failed to develop, maintain, or follow an FSVP for any imported foods, specifically cabbage, green prickly pear, and fresh cilantro imported from Mexico. The FDA rejected the firm's response as inadequate, noting no supporting documentation was provided, and demanded corrective action within 15 working days.

Yuyao City Boss Vegetable Factory - Record Fabrication and Acidified Food Violations

FDA inspected Yuyao City Boss Vegetable Factory Co. Ltd. in China from June 16 to June 17, 2025, finding the firm created and backdated approximately (b)(4) records during the inspection walk-through to cover acidified mustard stem production since 2023. The firm's acidified mustard stem products (whole, shredded, and sliced) were placed on Import Alert #99-38, 'Detention Without Physical Examination Due to Inadequate Process Control,' on October 23, 2025, subjecting them to DWPE when offered for import into the United States.

FDA Warning Letter: Kare Solutions LLC dba Zappy - Misbranded Compounded Semaglutide, Tirzepatide, and Liraglutide Products

FDA issued a Warning Letter to Kare Solutions LLC dba Zappy on February 20, 2026 for marketing misbranded compounded drug products including semaglutide, tirzepatide, and liraglutide through its website zappyhealth.com. The agency determined that Zappy's website falsely represented Zappy as the compounder of these drugs when it is not, and made misleading claims implying FDA approval. Under sections 502(a) and 502(bb) of the FDCA, compounded drug products are misbranded if their labeling or advertising is false or misleading. The company has 15 working days to respond with specific corrective actions including identifying actual product manufacturers, providing labeling samples, and addressing false claims.

FDA Warning Letter — The Father's Table, LLC — Listeria monocytogenes Contamination

The FDA inspected The Father's Table, LLC's food manufacturing facility in Sanford, FL from January 13 to February 13, 2025, and found Listeria monocytogenes contamination in the production environment, including on food-contact surfaces (metal conveyor belt, depanning room table) and non-food-contact areas (floor drains, floor holes). Whole genome sequencing confirmed a single unique L. monocytogenes strain with no match in the NCBI database. The firm's ready-to-eat cheesecake and cake roll products are deemed adulterated under section 402(a)(4) of the FD&C Act. The firm halted production, conducted root cause analysis, and destroyed affected product, but FDA concerns remain regarding sanitation controls and facility design. The FDA requires a written response within 15 working days detailing specific corrective steps.

FDA Warning Letter to John Yoder Farm for Salmonella Enteritidis Shell Egg Violations

FDA issued a Warning Letter to John Yoder Farm (Monte Vista, CO) on November 28, 2025, following an inspection from July 8-10, 2025, citing violations of 21 CFR Part 118 (Prevention of Salmonella Enteritidis in Shell Eggs). The farm, which operates approximately (b)(4) layers and distributes shell eggs to the table market, failed to implement a written SE Prevention Plan as required for producers with 3,000+ laying hens. Observed violations include employees keeping birds at home (biosecurity breach), presence of flies in the egg collection room, and a cat and dog observed entering the collection room. FDA requires a written response within 15 working days detailing corrective actions.

FDA Warning Letter to Strut Health, LLC for Misbranded Compounded Drugs

FDA issued a Warning Letter to Strut Health, LLC on February 20, 2026, for offering compounded semaglutide and tirzepatide drug products with false or misleading labeling and advertising in violation of sections 502(a) and 502(bb) of the FDCA. The website displayed 'Strut' on product labels implying Strut is the compounder when it is not, and made claims such as 'Generic Zepbound, Mounjaro' that falsely implied FDA approval. Failure to adequately address violations within 15 working days may result in legal action including seizure and injunction.

FDA Warning Letter to Diasol, Inc. for Medical Device Violations

FDA issued a Warning Letter to Diasol, Inc. on January 29, 2026, following an inspection from July 21 through August 19, 2025, at the firm's Phoenix, Arizona facility. The agency found that Diasol manufactures hemodialysis disinfectant products (Diasol Bicarb, Diasol Concentrate, Diasol Additives, and CirtiSol Concentrate) that are adulterated because the firm lacks FDA premarket approval (PMA) or an investigational device exemption (IDE), and misbranded because no premarket notification (510(k)) was submitted for the specific intended use of cleaning, decalcification, and heat disinfection of hemodialysis machines. Quality System Regulation violations were also cited under 21 CFR Part 820, including inadequate final acceptance procedures and release of finished products without required Dextrose testing results.

FDA Warning Letter to Beta Bionics, Inc. — Quality System Regulation Violations

FDA issued a Warning Letter to Beta Bionics, Inc. following an inspection from June 9–26, 2025, at the firm's Irvine, CA facility, citing Quality System Regulation violations under 21 CFR Part 820. The agency found the iLet Dosing Decision Software and iLet ACE Pump (iLet Bionic Pancreas System) to be adulterated within the meaning of Section 501(h) of the Federal Food, Drug, and Cosmetic Act. Key violations include failure to implement CAPAs for complaints reporting device malfunctions linked to serious adverse health outcomes, including diabetic ketoacidosis, and 107 serious injury Medical Device Reports for hypoglycemia attributed to use errors with insulin cartridges. Beta Bionics' verification of effectiveness for CAPA 0050 was also deemed inadequate for testing training materials against actual user populations.

FDA Warning Letter to GenoGenix LLC - 503B Outsourcing Facility Violations

FDA issued a Warning Letter to GenoGenix LLC, a 503B outsourcing facility in Boca Raton, FL, documenting violations of the Federal Food, Drug, and Cosmetic Act including use of unapproved bulk drug substances, multiple labeling deficiencies, failure to submit required reports, and insanitary conditions that caused compounded drug products to be adulterated. The facility compounded products including 5-Amino-1MQ and NAD+ that are not on the 503B bulks list and are not on the drug shortage list. Inspection revealed that injectable methylcobalamin contained only 65.3% of labeled strength and injectable B Complex contained only 43.1% of labeled dexpanthenol. Three patients were hospitalized after receiving NAD+ Lot GG121624-023 from the same vial, which was later found to contain excessive bacterial endotoxins at 3,360 EU/mL. The firm initiated a voluntary recall on July 30, 2025, and has ceased drug production and distribution.

FDA Warning Letter to Black Sheep Egg Company, LLC - Salmonella Contamination and Shell Egg Regulation Violations

FDA issued a Warning Letter to Black Sheep Egg Company, LLC on February 12, 2026, following an inspection of its shell egg processing facility in Walnut Ridge, Arkansas (August 20 – September 12, 2025). Investigators detected Salmonella spp. across seven serovars in environmental samples, including S. I 4,[5],12:i:- matching a 2025 human illness strain, S. Mbandaka matching a 2023 clinical isolate, and S. Braenderup widespread across processing equipment. The firm voluntarily recalled approximately 4.8 million eggs. Violations include insanitary conditions (open doors, fly infestation TNTC, broken egg residue on food-contact surfaces), inadequate sanitation procedures, and failure to comply with 21 CFR Part 118 refrigeration requirements, with eggs tempered above 45°F for up to 71 hours. FDA may pursue seizure, injunction, or administrative enforcement under 21 CFR 118.12(a).

FDA Warning Letter to Supercan Bully Sticks LLC for FSVP and Preventive Controls Violations

FDA issued a Warning Letter to Supercan Bully Sticks LLC documenting serious violations of the Federal Food, Drug and Cosmetic Act found during two inspections of their Miami facility between April 17 and May 22, 2025. The inspections revealed the firm lacked required Foreign Supplier Verification Programs for imported animal food products and failed to implement hazard analysis and risk-based preventive controls for animal food under 21 CFR Part 507, including no written food safety plan. These inspections were initiated following a voluntary Class 1 recall on March 28, 2025 of Supercan Pig Ear Slivers pet treats due to Salmonella enterica contamination detected by the Washington State Department of Agriculture. The firm has 15 working days from receipt of the letter to provide written corrective actions or face legal or regulatory action including seizure, injunction, or import refusal.

FDA Warning Letter to MedisourceRx

The FDA issued a warning letter to MedisourceRx on December 12, 2025, for failing to meet the conditions of section 503B of the FDCA. The inspection revealed that the outsourcing facility did not submit adverse event reports as required, violating federal drug laws.

FDA Warning Letter to East CK Trading Inc.

The FDA issued a warning letter to East CK Trading Inc. for significant violations of the Foreign Supplier Verification Program (FSVP) regulation. The company failed to develop and maintain an FSVP for imported foods, leading to potential refusal of admission and detention without physical examination.

FDA Warning Letter to Dynamic Stem Cell Therapy

The FDA issued a warning letter to Dynamic Stem Cell Therapy for misbranding an umbilical cord-derived stem cell product. The product is considered an unapproved new drug and an unlicensed biological product, violating the Federal Food, Drug, and Cosmetic Act. The FDA's review found claims on the company's website indicating the product is intended to diagnose, cure, mitigate, treat, or prevent disease.

FDA Warning Letter to AQ USA Inc. for Drug Manufacturing Violations

The FDA issued a warning letter to AQ USA Inc., d.b.a Ross Healthcare Inc., for significant Current Good Manufacturing Practice (CGMP) violations at its drug manufacturing facility in Lynden, Washington. The violations include inadequate laboratory testing for microbial contamination and failure to establish appropriate specifications for drug products.

FDA Warning Letter to A. Nelson & Co. Ltd

The FDA issued a warning letter to A. Nelson & Co. Ltd. for significant violations of Current Good Manufacturing Practice (CGMP) regulations, including inadequate microbial testing and unsupported expiration date extensions. The company's drug products were found to be adulterated.