Cosmetic Specialty Labs, Inc. – FDA Warning Letter, Sep 20, 2023

The FDA issued a Warning Letter to Cosmetic Specialty Labs, Inc. on February 29, 2024, following an inspection from September 11-20, 2023. The inspection revealed significant Current Good Manufacturing Practice (CGMP) violations for finished pharmaceuticals, rendering their drug products adulterated under 21 U.S.C. 351(a)(2)(B).

Key violations include: 1. **Quality Control Unit Failures (21 CFR 211.22):** The firm's quality unit (QU) failed to ensure CGMP compliance and product specifications. They approved drug products, like (b)(4), for distribution without complete finished product testing (analytical and microbial), and lacked adequate QU oversight, resources, and authority. 2. **Inadequate Production and Process Controls (21 CFR 211.100(a)):** The firm lacked appropriate process validation for drug products, including microbiological testing and accurate active ingredient specifications for (b)(4), and failed to validate other products with varying formulations. 3. **Failure to Test Components (21 CFR 211.84(d)(1) & (d)(2)):** The firm did not adequately test incoming components for identity, including ethanol for methanol and high-risk components like glycerin and propylene glycol for diethylene glycol (DEG) or ethylene glycol (EG) contamination