FDA 483 - Pure Source LLC - August 14, 2019

An FDA inspection of Pure Source LLC, a contract OTC drug manufacturer in Doral, FL, revealed significant deficiencies in its quality system, production controls, and material management. The firm failed to thoroughly investigate discrepancies, properly manage deviations, and adequately qualify component suppliers, with some issues being repeat observations from previous inspections. These findings indicate a concerning lack of adherence to good manufacturing practices.