FDA WARNING_LETTER - Hangzhou Glamcos Biotech Co., Ltd. - September 30, 2024

The FDA issued a Warning Letter to Hangzhou Glamcos Biotech Co., Ltd. on October 7, 2024, following a review of records submitted in response to a March 4, 2024, request. The facility, an OTC drug product manufacturer, was found to have significant Current Good Manufacturing Practice (CGMP) violations, rendering its drug products adulterated under 21 U.S.C. 351(a)(2)(B).

Key CGMP violations include: 1. Failure to conduct adequate finished drug product testing, including identity and strength of active ingredients, prior to release (21 CFR 211.165(a)). 2. Failure to perform identity testing on incoming components, particularly high-risk ingredients like glycerin and propylene glycol for DEG/EG contamination, and failure to qualify raw material suppliers (21 CFR 211.84(d)(1) and 211.84(d)(2)). 3. Failure to establish and follow an adequate stability testing program, including active ingredient testing, to support expiration dates (21 CFR 211.166(a)). 4. Failure to prepare complete batch production and control records (21 CFR 211.188).

Additionally, "disinpro multi-purpose ANTIBACTERIAL WIPES" was identified as an unapproved new drug