A new FDA Warning Letter for Chinese Company after the Review of Records

We recently covered a Warning Letter issued to a Chinese manufacturer for significant breaches of cGMP regulations concerning finished pharmaceuticals. The U.S. Food and Drug Administration (FDA) has now issued another Warning Letter, dated February 5, 2024, to a Chinese company registered as a manufacturer of over-the-counter (OTC) drug products in the United States. The FDA reviewed records submitted in response to a formal request for records and other information.

The violations highlighted in the letter include:

• Neglecting to conduct proper laboratory testing of OTC drug products before release.
• Use of an inappropriate device for testing.
• Failure to conduct adequate identity testing of incoming components used in drug product manufacturing.
• Inability to demonstrate that the chemical properties of the drug products remain acceptable throughout their labeled expiry period.

The FDA emphasizes the necessity of full release testing, encompassing identity, strength, and impurities, prior to drug release and distribution. Without such testing, there is no scientific evidence to ensure that the drug products meet appropriate specifications before release.

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 agency recommends engaging a qualified consultant to assist in meeting cGMP requirements. The company is given 15 working days to respond to the letter with plans to address the deficiencies.

For further information, please refer to the complete Warning Letter to Ningbo Poplar Daily-Use on the FDA's website.