EnviroServe Chemicals & Cleaners Ltd. – FDA Warning Letter, Sep 9, 2024

The FDA issued a Warning Letter to EnviroServe Chemicals & Cleaners Ltd. on September 9, 2024, following a review of records submitted in response to a Section 704(a)(4) request. The facility, an OTC drug manufacturer, was found to have significant Current Good Manufacturing Practice (CGMP) violations, rendering its drug products, including SOPURE ANTISEPTIC SKIN CLEANSER, adulterated under 21 U.S.C. 351(a)(2)(B).

Key CGMP violations include: 1. Failure to conduct identity testing for each component and validate supplier test analyses (21 CFR 211.84(d)(1) & 211.84(d)(2)), specifically lacking methanol testing for ethanol. 2. Failure to perform adequate finished drug product testing for conformance to specifications, including active ingredient identity and strength (21 CFR 211.165(a)). 3. Failure to establish an adequate stability testing program to determine appropriate storage conditions and expiration dates (21 CFR 211.166(a)). 4. Failure to establish an adequate quality control unit with proper authority and oversight (21 CFR 211.22(a)).

Additionally, SOPURE ANTISEPTIC SKIN CLEANSER is an unapproved new drug, marketed in violation of 2