Hangzhou Glamcos Biotech Co., Ltd. — FDA Warning Letter Findings

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)). Based on the stability records and information you provided, you did not demonstrate the quality attributes of your drug products remain acceptable throughout the labeled expiry period. For example, you did not include active ingredient testing as part of your stability program. 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 prepare batch production and control records with complete information relating to the production and control of each batch of drug product produced (21 CFR 211.188). Based on the records and information you provided, your batch production records were inadequate. For example, your batch production records for OTC drug products lacked documentation that each significant step in the manufacture, processing, packing, or holding of the batch was…

Your firm failed to conduct at least one test to verify the identity of each component of a drug product. Your firm also failed to validate and establish the reliability of your component supplier’s test analyses at appropriate intervals (21 CFR 211.84(d)(1) and 211.84(d)(2)). Your firm manufactured OTC drug products including antibacterial wet wipes used for reducing bacteria on skin. Based on the records and information you provided, you did not demonstrate you adequately…