FDA 483 - Pharmasol Corporation - June 14, 2021

An FDA inspection of Pharmasol Corporation, a human drug contract manufacturer in South Easton, MA, revealed significant and repeat deficiencies across multiple areas of its operations. The firm failed to thoroughly investigate numerous discrepancies impacting distributed drug products, including illegible expiration dates, broken actuators, and stability failures. Additionally, the inspection found inadequate quality control unit procedures, insufficient equipment qualification, failures to follow production controls, dirty manufacturing equipment, lack of employee training, and poor computer system controls for master batch records.