FDA 483 - Active Cosmetics Manufacturing Inc - October 31, 2025

Active Cosmetics Manufacturing Inc, a contract manufacturer in Orlando, FL, was cited with seven significant observations during an FDA inspection. The findings indicate a severe lack of adherence to Good Manufacturing Practices, including inadequate investigations for out-of-specification results, stability failures, and deviations, as well as deficiencies in laboratory controls, process validation, component testing, and equipment cleaning. Several observations are repeats from previous inspections, highlighting persistent systemic issues.