FDA Issues Warning Letter to Chinese Manufacturer Over CGMP Violations

On February 25, 2025, the U.S. FDA issued a Warning Letter to a Chinese company, Linghai ZhanWang Biotechnology Co., Ltd for significant violations of Current Good Manufacturing Practice (CGMP) regulations. The facility, which manufactures OTC drug products, including antimicrobial wipes, failed to meet essential quality standards.

Key Violations Identified:

• Inadequate Component Testing: The firm did not test ethanol for methanol contamination or glycerin for toxic impurities like diethylene glycol (DEG) and ethylene glycol (EG).
• Deficient Stability Testing: Labeled expiration dates lacked scientific validation, and stability studies were not conducted under proper long-term storage conditions.
• Weak Quality Control Unit: The company’s quality control team lacked sufficient oversight to ensure CGMP compliance.

Due to these violations, the FDA placed the company’s products on Import Alert 66-40, restricting their entry into the U.S. The company must submit a corrective action plan within 15 working days or face further regulatory action.

24-03-2025

• Pharma GMP
• Food GMP
• Clinical Research
• Medical Device
• Environmental Health and Safety
• Healthcare
• Nutrition