FDA WARNING_LETTER - Creative Essences Inc - March 25, 2025

The FDA issued a Warning Letter to Creative Essences, Inc. following an inspection of its Santa Fe Springs drug manufacturing facility from March 19 to 25, 2025. The letter details significant violations of Current Good Manufacturing Practice (CGMP) regulations, rendering the company"s drug products adulterated under the Federal Food, Drug, and Cosmetic Act.

Key issues included the firm"s failure to thoroughly investigate unexplained discrepancies and out-of-specification (OOS) results, such as an OOS active pharmaceutical ingredient, microbial OOS from the water system, and stability failures for a sunscreen product. The company"s quality unit did not adequately identify root causes, implement effective corrective actions, or assess the impact on other batches. Furthermore, Creative Essences, Inc. lacked adequate laboratory controls, including insufficient sampling and testing procedures for finished drug products, and failed to demonstrate the suitability of its microbiological test methods. The FDA also identified one drug product as an unapproved new drug and misbranded.

The FDA requires comprehensive, independent assessments and remediation plans for the company"s deviation investigation and corrective and preventive action (CAPA) programs. This includes improving investigation competencies, root cause analysis, and quality unit oversight. Additionally, the company must conduct an independent assessment of its laboratory practices, providing a detailed remediation plan, a list of all specifications, and a plan for full chemical and microbiological testing of retain samples for all distributed drug products currently within their expiry period.