FDA 483 - Creative Essences Inc - March 25, 2025

Creative Essences Inc, a drug manufacturer in Santa Fe Springs, CA, was inspected by the FDA from March 19-25, 2025. The inspection revealed significant deficiencies across quality, laboratory, materials, facilities, equipment, and production systems, many of which were repeat observations from a previous 2020 inspection. Key issues include inadequate investigations, lack of proper quality control procedures, insufficient employee training, unconfirmed stability data for drug products, and unvalidated cleaning and manufacturing processes.