FDA 483 - Cosco Enterprises Inc. - March 26, 2024

An FDA inspection of Cosco Enterprises Inc., an OTC drug manufacturer in Ridgewood, NY, revealed ten significant deficiencies in their manufacturing and quality control processes for Tincture of Green Soap U.S.P. The observations highlight systemic failures in stability testing, raw material control, process validation, batch record completeness, and personnel training. Notably, several issues were repeat observations from prior inspections, indicating a lack of sustained corrective action.