FDA 483 - Pharmasol Corporation - February 10, 2022

Pharmasol Corporation, a human and animal drug contract manufacturer in South Easton, MA, was cited for numerous significant deficiencies during an FDA inspection. The observations highlight systemic failures in quality control, including inadequate investigations into complaints and cleaning failures, lack of proper equipment maintenance, and insufficient employee training. These issues indicate a broad lack of adherence to cGMP regulations, posing potential risks to drug product quality and patient safety.