FDA Flags Major GMP Failures at Chinese OTC Drug Manufacturer

The U.S. FDA issued a Warning Letter on October 10, 2025 (published October 21), citing serious lapses in Current Good Manufacturing Practice (CGMP) compliance at a Chinese OTC drug producer. The agency found missing product testing for identity and potency, absent stability studies to justify expiry dates, and unverified raw material testing. Critical documentation gaps—including missing process validation and incomplete batch records—prevented FDA from confirming manufacturing consistency or product quality. Due to these basic yet severe deficiencies, the company’s products were added to Import Alert 66-40, banning U.S. entry. The FDA urged the firm to hire an independent CGMP expert to conduct a full six-system audit and guide corrective measures. The full Warning Letter to Foshan Yiying Hygiene Products Co., Ltd. is available on the FDA website.

27-10-2025