Global Cosmetics Company Limited — FDA Warning Letter Findings

Your firm failed to conduct at least one test to verify the identity of each component of a drug product (21 CFR 211.84(d)(1). You manufactured OTC drug products including hand sanitizer. 1 Based on the records and information you provided, you did not demonstrate that you are adequately testing the identity of incoming components used in the manufacture of your drug products. You also did not demonstrate that you are adequately testing your active ingredient ethanol for…

Your firm failed to establish and follow an adequate written testing program designed to assess the stability characteristics of drug products and to use results of stability testing to determine appropriate storage conditions and expiration dates (21 CFR 211.166(a)). The records and information you provided did not demonstrate that your firm has an adequate stability program for the OTC hand sanitizer drug products that you manufacture. For example, your firm provided a stability test report which only included 12 weeks of stability data for a batch of hand sanitizer. In addition, you did not provide data demonstrating that adequate chemical and microbiological testing is performed on your drug products during stability testing. Without appropriate stability studies, you do not have scientific evidence to support whether your drug products meet established specifications and retain their quality attributes through their labeled expiry.

Your firm failed to establish an adequate quality control unit with the responsibility and authority to approve or reject all components, drug product containers, closures, in-process materials, packaging materials, labeling, and drug products (21 CFR 211.22(a)). The records and information you provided demonstrate that your quality unit (QU) did not effectively exercise its responsibilities to oversee the quality of your drug manufacturing operations. Your QU is responsible…