Zhejiang Qimei Cosmetics Co., Ltd. – FDA Warning Letter, Nov 7, 2024

The FDA issued a Warning Letter to Zhejiang Qimei Cosmetics Co., Ltd. (FEI 3018321301) on November 7, 2024, following a review of records submitted per section 704(a)(4) of the FD&C Act. 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 violations include: 1. **Failure of Quality Control Unit (QCU) Responsibilities (21 CFR 211.22):** The QCU did not ensure OTC isopropyl alcohol (IPA) prep pads, labeled as sterile, were rendered sterile by an appropriate manufacturing process. 2. **Inadequate Finished Product Testing (21 CFR 211.165(a)):** The firm failed to adequately test OTC IPA prep pads for identity and strength of IPA prior to release. 3. **Insufficient Component Testing (21 CFR 211.84(d)(1)):** The firm did not adequately test incoming glycerin and propylene glycol for diethylene glycol/ethylene glycol limits, or ethanol and IPA for methanol limits, which are high-risk impurities.

The FDA recommends engaging a qualified CGMP consultant to evaluate operations and perform