Deqing Jiarou Daily Chemical Co., Ltd. – FDA Warning Letter, Mar 18, 2024

The FDA issued a Warning Letter to Deqing Jiarou Daily Chemical Co., Ltd. on March 18, 2024, following a review of records submitted on September 12, 2022, under section 704(a)(4) of the FD&C Act. The facility, registered as an OTC drug 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 violations include: 1. Failure to conduct identity testing for each component of a drug product (21 CFR 211.84(d)(1)), specifically not testing incoming components, including ethanol for methanol, used in Antibacterial Hand Sanitizer. 2. Failure to perform appropriate laboratory determination of satisfactory conformance to final specifications for each batch of drug product, including active ingredient identity and strength, prior to release (21 CFR 211.165(a)). 3. Failure to establish and follow an adequate written stability testing program for drug products (21 CFR 211.166(a)), with only four weeks of stability data provided and no demonstration of appropriate chemical and microbiological testing during studies. 4. Failure to establish an adequate quality control unit with the authority to approve or reject materials and products (21