FDA 483 - Safrel Pharmaceuticals LLC - January 30, 2026

Safrel Pharmaceuticals LLC, an own-label distributor and warehouse of drug products and dietary supplements in Dayton, NJ, was inspected from January 13-30, 2026. The inspection revealed significant deficiencies across quality control, production procedures, facility maintenance, and record-keeping for both drug products and dietary supplements. These issues indicate a severe lack of fundamental good manufacturing practices and quality oversight.