Advanced Cosmetic Research Laboratories, Inc. – FDA 483, Jun 26, 2026

An FDA inspection of Advanced Cosmetic Research Laboratories, Inc. in Chatsworth, CA, an OTC drug manufacturer, revealed significant and repeat deficiencies across multiple systems. The firm failed to establish adequate production and process controls, including process validation and hold-time studies, and lacked proper equipment qualification and cleaning validations for shared equipment. Additional concerns included deficient component testing, unqualified suppliers, inadequate investigations into out-of-specification results, personnel non-compliance with SOPs, and insufficient laboratory controls.