FDA warns Safrel Pharmaceuticals over significant CGMP violations

11th September 2026

Summary: Following an inspection of Safrel Pharmaceuticals’ New Jersey facility in January 2026, FDA identified significant violations of Current Good Manufacturing Practice (CGMP) requirements for finished pharmaceuticals. Key concerns included inadequate Quality Unit oversight, insufficient procedures for qualifying and monitoring suppliers and contract manufacturers, a lack of Certificates of Analysis for incoming products, poor segregation and control of products within the warehouse, and inadequate lot-level traceability. FDA also raised concerns about packaging and labelling activities for which the company could not provide sufficient documentation. The agency stressed that companies remain responsible for the quality of their medicines when using contract manufacturers and recommended that Safrel engage a qualified CGMP consultant. The company was given 15 working days to respond with details of its corrective actions.

Link: FDA Warning Letter: Safrel Pharmaceuticals LLC

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