Jiangsu Meifan Biotechnology Co. Ltd. – FDA Warning Letter, Apr 9, 2024

On April 3, 2024, the FDA issued a Warning Letter to Jiangsu Meifan Biotechnology Co. Ltd., FEI 3017005720, a manufacturer of OTC drug products in China. The letter followed a review of records submitted on August 15, 2022, pursuant to section 704(a)(4) of the FD&C Act.

The FDA found significant violations of Current Good Manufacturing Practice (CGMP) regulations (21 CFR, parts 210 and 211), rendering the firm's drug products adulterated under section 501(a)(2)(B) of the FD&C Act.

Key violations include: 1. **Failure to conduct adequate finished drug product testing (21 CFR 211.165(a))**: The firm did not demonstrate appropriate laboratory determination of satisfactory conformance to final specifications, including identity and strength of active ingredients, prior to release. For example, test reports for antimicrobial hand wipes lacked assay tests for active ingredient content or impurities. 2. **Failure to establish an adequate quality control unit (21 CFR 211.22(a))**: The firm's quality unit (QU) did not effectively oversee the quality of drug manufacturing operations, raising concerns about its CGMP oversight.

The FDA recommends engaging a qualified consultant (21 CFR 211