Foshan Biours Biosciences Co., Ltd. – FDA Warning Letter, Mar 10, 2021

This FDA Warning Letter, dated March 10, 2021, addresses Foshan Biours Biosciences Co., Ltd. (FEI 3011474550) in China, an OTC drug product manufacturer. The letter summarizes significant violations of current good manufacturing practice (CGMP) regulations (21 CFR, parts 210 and 211), rendering their 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 distributed OTC (b)(4) Patch without sufficient testing for identity and strength of the active ingredient, (b)(4), prior to release. Required actions include providing chemical and microbial specifications, an action plan for testing retain samples of all in-expiry U.S.-distributed batches, and a comprehensive, independent assessment of laboratory practices. 2. **Failure to establish and follow adequate written procedures for equipment cleaning and maintenance (21 CFR 211.67(b))**: The firm lacked validated cleaning procedures for non-dedicated equipment used in manufacturing and packaging the OTC (b)(4) Patch, raising cross-contamination concerns. Required actions include developing an adequate cleaning validation program, addressing worst-case scenarios, and updating SOPs for cleaning procedure verification and