FDA Warning Letter: Chinese API Manufacturer on Import Alert Due to CGMP Violations

The U.S. Food and Drug Administration (FDA) has issued a Warning Letter dated 05 February 2025, citing significant deviations from Current Good Manufacturing Practice (CGMP). A facility located in China was found to have multiple compliance deficiencies following a review of records submitted in response to an FDA request. The firm manufactures Active Pharmaceutical Ingredients (APIs) that were distributed in the United States.

Key CGMP Violations

The first aspect mentioned is the failure to test the identity of each lot of incoming production material. The company did not perform adequate identity testing on each shipment or each lot of incoming materials. The FDA points out that, without proper testing, there is no assurance that raw materials meet established specifications before use in drug manufacturing.

The second point concerns deficiencies in Quality Unit oversight: The firm’s Quality Unit (QU) failed to establish and implement a robust system for the approval or rejection of raw materials, intermediates, and packaging components. Effective QU oversight is essential for maintaining drug quality and ensuring CGMP compliance.

Regulatory Consequences

As a result of these findings, the FDA has placed the facility’s products on Import Alert 66-40 ("Detention Without Physical Examination of Drugs From Firms Which Have Not Met Drug GMPs") as of 17 January 2025.

The company is required to submit a detailed plan outlining how it will conduct identity testing for all incoming materials and how to ensure supplier qualification and oversight. Due to the severity of the deficiencies, the FDA advises the company to engage a qualified CGMP consultant to evaluate operations and assist with compliance efforts.

For further details, access the full Warning Letter to Chengdu Innovation Pharmaceutical Co., Ltd. on the FDA’s website.