FDA 483 - Cosmetic Enterprises Ltd - September 26, 2025

An FDA inspection of Cosmetic Enterprises Ltd in Pacoima, CA, a drug manufacturer, revealed numerous and significant cGMP deficiencies, including several repeat observations. The firm failed to establish and follow written procedures for quality control, adequately control rejected components, verify raw material identity, and validate processes. Additionally, issues were noted with laboratory controls, investigation of out-of-specification results, equipment validation, stability testing, reserve sample retention, and computer system access controls.