FDA 483 - Samson Pharmaceuticals, Inc - March 25, 2016

Samson Pharmaceuticals, Inc., an OTC drug manufacturer in Commerce, CA, was inspected by the FDA, revealing significant deficiencies. The firm failed to conduct annual product reviews, lacked proper quality control unit authority for product release, and did not routinely verify equipment. Additionally, critical validation records were unavailable, and employee GMP training was insufficient, indicating a broad lack of adherence to cGMP requirements.