FDA Issues Warning to Wuhu Nuowei Chemistry Co., Ltd. for Major GMP Violations

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:

• Inadequate Test Methods: The company used impurity tests based on the Chinese Pharmacopeia without verifying equivalence to U.S. Pharmacopeia (USP) standards. Some batches even exceeded USP impurity limits.
• Poor Cleaning Validation: Cleaning for multipurpose equipment relied on visual inspection only, without microbiological or chemical testing, risking cross-contamination.
• Lack of Stability Data: Insufficient data was available to support product shelf life claims.

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