Global Cosmetics Company Limited – FDA Warning Letter, May 7, 2024

On April 30, 2024, the FDA issued Warning Letter 320-24-35 to Global Cosmetics (China) Company Limited, an OTC drug product manufacturer. The letter, resulting from a review of records submitted on September 12, 2022, pursuant to section 704(a)(4) of the FD&C Act, cited significant Current Good Manufacturing Practice (CGMP) violations, rendering their drug products adulterated under 21 U.S.C. 351(a)(2)(B).

Key violations include: 1. Failure to conduct identity testing for each component of drug products, specifically inadequate testing of incoming components and active ingredient ethanol for methanol (21 CFR 211.84(d)(1)). 2. Failure to establish and follow an adequate written stability testing program, with insufficient data (e.g., only 12 weeks of data for hand sanitizer) and lack of demonstrated chemical and microbiological testing during stability studies (21 CFR 211.166(a)). 3. Failure to establish an adequate quality control unit with authority to approve or reject materials and products, indicating the quality unit did not effectively oversee manufacturing operations (21 CFR 211.22(a)).

The FDA recommends engaging a qualified CGMP consultant to perform a comprehensive six-system audit and evaluate corrective actions