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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 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.

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.

Health Districts Urge Planning for Severe Weather

The Hampton & Peninsula Health Districts in Virginia are urging residents to plan for severe spring weather, including tornadoes, thunderstorms, and flooding. The notice provides safety tips and encourages participation in Severe Weather Awareness Week activities.

IntelliVue MX Patient Monitor System EC10 Recall

Health Canada has issued a Type II recall for the Philips IntelliVue MX Patient Monitor System-IntelliBridge Module EC10. The recall is due to a potential safety issue where the system may fail to alarm for 'No Device Data' INOP, affecting patient safety. Healthcare providers are advised to contact the manufacturer for additional information.