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FDA Warning Letter to idripejuice.com for Tobacco Products

The FDA issued a warning letter to idripejuice.com for selling electronic nicotine delivery system (ENDS) products to individuals under 21. The company's products were found to be misbranded due to these sales, violating the Federal Food, Drug, and Cosmetic Act.

FDA Warning Letter to Exactech Inc. dba Advita Ortho

The FDA issued a Warning Letter to Exactech, Inc. dba Advita Ortho on December 19, 2025, citing violations of the Quality System Regulation (21 CFR Part 820) during an inspection of their Sarasota, Florida facility. The letter details failures in process control procedures for manufacturing medical devices, specifically the Equinoxe Reverse Shoulder Compression Screw and related accessories.

FDA Warning Letter to Raw Bistro Inc. for CGMP Violations

The FDA issued a warning letter to Raw Bistro Inc. for violations of Current Good Manufacturing Practice (CGMP) and Hazard Analysis and Risk-Based Preventive Controls for Food for Animals. The facility's product was found to be adulterated due to the presence of Salmonella, leading to a Class I recall.

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

The FDA issued a warning letter to El Rey USA Meats & Seafood Inc. on February 19, 2026, citing serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation. This follows a previous inspection and warning in January 2023, indicating a failure to implement required verification procedures for imported fish and fishery products.

FDA Warning Letter to Tentamus India Private Limited

The FDA issued a warning letter to Tentamus India Private Limited for significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals. The violations include the quality control unit failing to ensure CGMP compliance and the destruction or improper handling of analytical records.

FDA Warning Letter to Nu Skin Enterprises for Drug Listing Violations

The FDA issued a warning letter to Nu Skin Enterprises for violations related to drug listing obligations under the Federal Food, Drug, and Cosmetic Act. The company failed to update manufacturing establishment information and has 61 inactivated drug listings. The FDA requires corrective action within 15 working days.

FDA Warning Letter to SSS AUSTAR LLC for Tobacco Products

The FDA issued a warning letter to SSS AUSTAR LLC for illegally marketing nicotine pouch products without required premarket authorization. The company's product, ZIMO MINT 6MG, is considered adulterated and misbranded under the Federal Food, Drug, and Cosmetic Act.

FDA Warning Letter to Fareva Morton Grove

The FDA issued a warning letter to Fareva Morton Grove for significant violations of Current Good Manufacturing Practice (CGMP) regulations. The violations relate to equipment design and control in the manufacturing of over-the-counter drug products, leading to adulterated drugs.

FDA Warning Letter to Simtra BioPharma Solutions

The FDA issued a warning letter to Simtra BioPharma Solutions on March 3, 2026, citing significant violations of Current Good Manufacturing Practice (CGMP) regulations at their German drug manufacturing facility. The violations relate to inadequate controls in aseptic processing areas, leading to potential adulteration of drug products intended for the U.S. market.

FDA Warning Letter to snushaven.com for Nicotine Pouches

The FDA issued a warning letter to snushaven.com for selling misbranded nicotine pouches, specifically for selling to individuals under 21. The company is required to take prompt action to address violations of the Federal Food, Drug, and Cosmetic Act.