FDA slaps two Chinese API manufacturers with warning letters over cGMP violations
The FDA has issued warning letters to two Chinese active pharmaceutical ingredient (API) manufacturers, Wuhu Nuowei Chemistry and Chengdu Innovation Pharmaceutical, for “significant” deviations from current Good Manufacturing Practice (cGMP).
The agency placed both companies on Import Alert 66-40, blocking their products from entering the U.S. market.
Wuhu Nuowei: inadequate testing, poor quality oversight
Following an inspection of Wuhu Nuowei Chemistry’s facility in September 2024, the FDA found that the company failed to ensure its APIs met quality and purity standards. The firm used impurity testing methods from the Chinese Pharmacopeia without proving they were equivalent to the U.S. Pharmacopeia (USP) standards. A batch of API imported into the U.S. exceeded USP impurity limits, rendering the drug adulterated under the Federal Food, Drug, and Cosmetic Act.
The FDA also cited deficiencies in Wuhu Nuowei’s stability program, noting a lack of data to support retest and expiration dates. Additionally, the company relied solely on visual inspection to determine equipment cleanliness rather than performing analytical testing to confirm the removal of potential contaminants.
In response, Wuhu Nuowei Chemistry ceased drug production for the U.S. market and deregistered its facility as a drug manufacturer. The FDA has requested clarification on whether the company plans to resume operations.
Chengdu Innovation: failure to test raw materials
Chengdu Innovation Pharmaceutical was cited by the FDA for failing to test the identity of each lot of incoming materials used in drug manufacturing. Without this testing, the company could not confirm whether raw materials met required specifications before use, according to the regulator.
The FDA also found that Chengdu Innovation’s quality unit lacked a system for approving or rejecting raw materials, intermediates, packaging, and labeling materials. The agency stated that this failure compromised overall product quality and safety.
The regulator has recommended that Chengdu Innovation hire a cGMP consultant to conduct a full assessment of its manufacturing processes. The company must submit a corrective action plan to the FDA addressing the identified deficiencies.