Cosmobeauti Laboratories & Manufacturing Inc. – FDA Warning Letter, Mar 15, 2023

The FDA inspected Cosmobeauti Laboratories & Manufacturing Inc. from March 6-15, 2023, identifying significant Current Good Manufacturing Practice (CGMP) violations for finished pharmaceuticals, rendering their drug products adulterated. The company's response to the FDA 483 was deemed inadequate.

Key violations include: 1. **Quality Control Unit Failure:** The Quality Unit (QU) failed to ensure CGMP compliance and product specifications. Batch production record steps were backdated, raising data integrity concerns. The FDA requires a determination of robust procedures, QU oversight, complete batch reviews, and top management support for quality. 2. **Inadequate Testing:** The firm failed to perform microbiological testing on each batch and lacked sufficient stability data to support assigned shelf-lives for OTC drug products. The FDA requires stability-indicating methods, stability studies for each product, an ongoing stability program, and detailed attribute testing. 3. **Insufficient Production and Process Controls:** Batch production records for sunscreen products lacked adequate details (e.g., equipment identification, critical parameters, unrecorded steps). The firm also lacked adequate validation for its water system and cleaning validation for non-dedicated equipment. The FDA requires a water system validation report, cleaning validation for various drug types, and updated SOPs.

The FDA noted these were repeat observations from a November 2017 inspection, indicating inadequate executive management oversight. The firm's quality systems and data integrity practices are deemed