FDA 483 - Pharmasol Corporation - August 20, 2018

Pharmasol Corporation in South Easton, MA, a human drug manufacturer, received a Form FDA 483 with nine observations highlighting significant deficiencies in its quality system and manufacturing practices. Repeated observations from previous inspections indicate a persistent failure to adequately investigate discrepancies, follow quality control procedures, maintain stability testing programs, and ensure facility and equipment cleanliness. The findings suggest a systemic lack of control over critical processes, potentially impacting drug product quality and patient safety.