FDA 483 - Cosmetic Science Laboratories, LLC - September 20, 2022

An FDA inspection of Cosmetic Science Laboratories, LLC, a contract manufacturer of over-the-counter drug products in Torrance, CA, revealed significant Current Good Manufacturing Practice (CGMP) deficiencies. The firm failed to establish adequate written procedures and controls for production, quality, laboratory, and equipment systems. Key issues included a lack of process and water system validation, incomplete batch records, insufficient component testing, and an absence of a stability testing program for its sunscreen products.