The FDA has issued a Warning Letter to Wuhu Nuowei Chemistry Co., Ltd. for serious Good Manufacturing Practice (GMP) violations, resulting in the company’s addition to Import Alert 66-40—banning its products from entering the U.S.
Key Violations:
The FDA is demanding a comprehensive risk assessment, including potential recalls, and a complete overhaul of the company’s cleaning and quality validation processes. It recommends engaging a GMP consultant to correct systemic quality management failures.
22-04-2025