FDA 483 - Advanced Cosmetic Research Laboratories, Inc. - January 17, 2025

An FDA inspection of Advanced Cosmetic Research Laboratories, Inc. in Chatsworth, CA, revealed significant deficiencies across multiple systems, including production, quality, materials, facilities, and laboratory controls. The firm failed to establish adequate written procedures, perform process validation, conduct thorough investigations into out-of-specification results, and maintain proper control over data and facility conditions. Several observations were noted as repeat findings, indicating persistent issues with GMP compliance.