Another FDA Warning Letter for Chinese Company based on Review of Records

We recently reported on a Warning Letter to a Chinese manufacturer regarding significant violations of cGMP regulations for finished pharmaceuticals.

The U.S. Food and Drug Administration (FDA) has now issued another Warning Letter, dated 05 February 2024, again to a Chinese company registered as a manufacturer of over-the-counter (OTC) drug products in the United States. Similarly, the authority has reviewed the records that were submitted in response to a formal request for records and other information.

The violations include:

  • Failure to conduct appropriate laboratory testing of the OTC drug products prior to release.
  • The use of a unsuitable device for testing.
  • Failure to conduct proper identity testing of incoming components used in the manufacture of the drug products.
  • Failure to demonstrate that the chemical properties of the drug products remain acceptable throughout the labeled expiry period.

The authority points out that "full release testing, including for identity, strength, and impurities, must be performed prior to drug release and distribution. Without adequate testing, there is no scientific evidence to assure that your drug products conform to appropriate specifications before release." Furthermore, "component testing is fundamental to quality. Without adequate testing, you do not have scientific evidence that your raw materials conform to appropriate specifications before use in the manufacture of your drug products."

The FDA requests the company to provide detailed corrective actions for each violation, including plans for chemical and microbiological testing, component testing, and stability assessment. The authority suggests engaging a qualified consultant to assist in meeting cGMP requirements. The firm is given 15 working days to respond to the letter with plans for addressing the deficiencies.

For further details, please have a look at the complete Warning Letter to Ningbo Poplar Daily-Use on the FDA's website.

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