FDA WARNING_LETTER - Safrel Pharmaceuticals LLC - January 30, 2026

The FDA issued a Warning Letter to Safrel Pharmaceuticals LLC following an inspection of its Dayton, New Jersey facility conducted from January 13 to January 30, 2026. The inspection revealed significant violations of Current Good Manufacturing Practice (CGMP) regulations, as defined under the Federal Food, Drug, and Cosmetic Act. These failures led the FDA to classify the company’s over-the-counter drug products as adulterated.

Primary violations included a severe lack of quality unit oversight and the absence of written procedures for drug manufacturing and distribution. Specifically, Safrel failed to maintain quality agreements or verify the quality of products received from contract manufacturers. Inspectors also found poor warehousing practices, where unlabeled, expired, and finished drug products were stored together without proper segregation, increasing the risk of mix-ups. Additionally, the company lacked a system for lot-level traceability, which is essential for conducting effective product recalls.

The FDA recommends that Safrel hire a professional CGMP consultant to address these systemic failures. The company is required to submit a comprehensive remediation plan within 15 working days. This plan must include a detailed assessment of the quality unit’s authority, a formal supplier qualification program, improved inventory management procedures, and a robust documentation system for tracking drug lots. Failure to correct these issues promptly may result in legal action, such as product seizures or the withholding of export certificates.