FDA Warning Letter for Chinese Company based on Review of Records

The U.S. Food and Drug Administration (FDA) has issued a Warning Letter to a Chinese manufacturer regarding significant violations of cGMP regulations for finished pharmaceuticals. The document dated 17 November 2023 was published on the FDA Website on 06 February 2024.

The company's facility is registered as a manufacturer of over-the-counter (OTC) drug products. The authority has reviewed the records that were submitted in response to a formal request for records and other information.

The FDA already placed the firm on Import Alert 66-40 ("Detention Without Physical Examination of Drugs From Firms Which Have Not Met Drug GMPs").

Key Violations

The Warning Letter lists findings in the following areas:

  • Failure to test incoming components: The firm could not demonstrate that incoming components were conforming with written specifications for purity, strength, and quality. Specifically, the firm failed to conduct identity testing of incoming lots of active pharmaceutical ingredients (APIs) and relied solely on supplier certificates of analysis (COAs) without verifying the information.
  • Inadequate stability program documentation: The firm provided accelerated study reports for some products but failed to provide evidence of long-term stability studies to corroborate product stability projections from the accelerated studies. Additionally, there was a lack of documentation for the stability program.

Next Steps

The company is given 15 working days to respond with corrective actions and preventive measures. Failure to do so may result in further regulatory action, including the withholding of product approvals and refusal of admission into the United States.

The FDA recommend engaging a qualified cGMP consultant to evaluate operations and assist in meeting regulatory requirements.

For further information, please see the complete Warning Letter to Nantong Furuida Packaging Products Co., Ltd. 

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