fda

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 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 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 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 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 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 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 Early Alert: Erbe USA Cryoprobes Rupture Risk

The FDA issued an Early Alert regarding Erbe USA Flexible Cryoprobes due to a risk of rupture during activation, potentially causing injuries and hearing loss. Erbe USA has recalled affected lots and recommended discontinuing use.

FDA Guidance: Flavored ENDS Premarket Applications

The FDA has issued guidance to assist with premarket tobacco product applications (PMTAs) for flavored electronic nicotine delivery systems (ENDS). This guidance, intended to improve submission and review efficiency, focuses on considerations related to youth risk. The document is non-binding and aims to inform potential future rulemaking.

FDA Draft Q&As on Biosimilar Development and BPCI Act

The FDA has issued a draft guidance document providing updated answers to common questions regarding biosimilar development and the Biologics Price Competition and Innovation Act (BPCI Act). This revision replaces a previous draft and focuses on specific Q&As related to the abbreviated licensure pathway for biological products.