FDA Slams Chinese Drugmaker for Major GMP Breaches

The U.S. Food and Drug Administration (FDA) issued a Warning Letter on October 10, 2025, to a Chinese manufacturer of OTC drugs (Foshan Yiying Hygiene Products Co), citing serious violations of Current Good Manufacturing Practices (CGMP). The agency found that the company failed to conduct essential product and raw material testing, perform stability studies, or validate its manufacturing processes. Incomplete batch records and missing analytical data prevented verification of product quality and consistency. The FDA described the lapses as fundamental, even noting that the firm did not maintain batch records for every product. Consequently, all products from the site were placed on Import Alert 66-40, halting their entry into the U.S. market. The agency urged the firm to hire an independent consultant for a full CGMP compliance audit.

29-10-2025