FDA WARNING_LETTER - Shantou Qiwei Industry Co., LTD - August 01, 2025

On June 2, 2026, the FDA issued a warning letter to Shantou Qiwei Industry Co., LTD, located in Guangdong, China, following a review of records requested in August 2025. The review revealed significant violations of Current Good Manufacturing Practice (CGMP) regulations, rendering the company"s over-the-counter (OTC) drug products adulterated under the Federal Food, Drug, and Cosmetic Act. The primary violation involves the company"s failure to adequately test drug components, specifically talc, for identity and purity. The FDA highlighted that talc is at high risk for asbestos contamination, a known carcinogen, yet the firm failed to conduct specific testing for asbestos or even basic identity tests before using the ingredient in manufacturing. Furthermore, the company relied on supplier certificates of analysis without validating the reliability of the results. The FDA also cited the company"s Quality Unit for failing to provide adequate oversight and for approving deficient manufacturing specifications. To resolve these issues, Shantou Qiwei Industry Co., LTD must provide a comprehensive risk assessment for all products currently on the market, perform asbestos testing on ingredient samples, and conduct a gap analysis comparing their procedures to United States Pharmacopeia standards. The firm must also submit a remediation plan to strengthen its Quality Unit. Failure to address these violations promptly may result in the FDA refusing the entry of the company"s products into the United States.