Yuyao YiJia Daily Chemical Co., Ltd. – FDA Warning Letter, Jan 26, 2021

The FDA issued a Warning Letter to Yuyao YiJia Daily Chemical Co., Ltd. on January 22, 2021, following a review of records submitted in response to a March 31, 2020, request. The facility, registered as an OTC drug manufacturer, was found to have significant violations of current good manufacturing practice (CGMP) regulations (21 CFR, parts 210 and 211), rendering its drug products adulterated.

Key violations include: 1. **Failure to conduct adequate finished drug product testing (21 CFR 211.165(a))**: The firm did not perform sufficient testing for identity and strength of active ingredients (e.g., for OTC products and hand sanitizers) prior to release, lacking proper test methods and specifications. 2. **Failure to verify identity of drug product components (21 CFR 211.84(d)(1))**: The firm relied on supplier Certificates of Analysis (COAs) without demonstrating raw material identity testing, supplier qualification, or COA verification. 3. **Failure to establish an adequate stability testing program (21 CFR 211.166(a))**: The firm lacked sufficient stability data, including active ingredient and microbiological testing, to support labeled expiry dates. 4. **Failure to establish adequate quality control unit responsibilities and procedures (21 CFR