FDA WARNING_LETTER - Columbia Cosmetics Manufacturing, Inc. - April 14, 2025

Columbia Cosmetics Manufacturing Inc., located at 1661 Timothy Dr., San Leandro, CA, was inspected by the FDA from April 7 to 14, 2025. The inspection revealed significant violations of Current Good Manufacturing Practice (CGMP) regulations, as outlined in Title 21 CFR parts 210 and 211, leading to the classification of their drug products as adulterated under section 501(a)(2)(B) of the FD&C Act.

Key violations included the failure to thoroughly investigate unexplained discrepancies or failures in product batches, particularly regarding out-of-specification (OOS) results for active pharmaceutical ingredients (APIs). The company inadequately addressed subpotency issues and released products without proper quality unit approval. Their response to the FDA"s Form 483 was deemed insufficient, lacking scientific justification and failing to extend investigations to other affected batches.

Additionally, Columbia Cosmetics failed to perform adequate identity testing on incoming components, relying excessively on supplier certificates of analysis without verifying their reliability. This oversight included high-risk components like glycerin, which were not tested for hazardous impurities such as diethylene glycol (DEG) or ethylene glycol (EG).

The company also did not establish adequate written procedures for production and process control, failing to validate manufacturing processes to ensure consistent product quality. Their response proposed retrospective validation but lacked commitment to prospective validation before product distribution.

The FDA requires Columbia Cosmetics to provide detailed corrective actions, including comprehensive investigations, validation of processes, and assurance of component integrity, to comply with CGMP standards and ensure product safety.