FDA Issues Warning letter to Chinese API Manufacturers, Wuhu Nuowei & Chengdu Innovation

FDA issued Warning letter to two Chinese API manufacturers following for cGMP violations including failing to meet USP specifications, inadequate stability data, deficient cleaning validation and inappropriate controls over incoming material testing.

The FDA inspected Wuhu Nuowei Chemistry Co., Ltd in September 2024 and identified serious cGMP violations.

• The test methods and impurity specifications for an API imported into US did not follow the USP, but rather the Chinese Pharmacopeia, and the impurity specification limits exceeded USP limits. The batch imported into US exceeded the USP limits for impurity thus rendering the API to be treated as adulterated.
• The retest period for the API was not backed by adequate stability data, and there was no analytical data to support the stability data table provided.
• Cleaning validation of shared manufacturing equipment used for API relied only on visual inspection and did not include any analytical or microbiology data or acceptance criteria for carry over residues.
• Wuhu Nuowei claimed that the API was only for R&D purpose and labelled as such, however FDA contended that the quantities shipped to US were much larger than typical R&D needs.

Due to the violations, the FDA placed the facility on Import Alert 66-40

Another API facility  Chengdu Innovation Pharmaceutical Co., Ltd received a Warning Letter and was placed on Import Alert 66-40 also due to significant cGMP violations. The facility failed to establish proper systems for approving or rejecting incoming materials and testing were inadequate. The Warning Letter was issued by FDA after reviewing documents submitted by Chengdu Innovation Pharmaceutical in April 2024.

• Warning letter: Wuhu Nuowei Chemistry Co., Ltd. (February 2025)
• Warning letter: Chengdu Innovation Pharmaceutical Co., Ltd. (February 2025)