FDA 483 - West Coast Cosmetics Inc - March 15, 2024

An FDA inspection of West Coast Cosmetics Inc., an OTC drug manufacturer in Chatsworth, CA, revealed significant deficiencies in their quality system, equipment maintenance, and personnel training. Key issues include the absence of an independent quality control unit (a repeat observation), inadequate cleaning validation and procedures for manufacturing equipment, an unqualified water system, and a lack of documented CGMP training for employees.