FDA Warning Letter for Chinese Manufacturer highlights the Importance of the Quality Unit

The U.S. Food and Drug Administration (FDA) has issued a warning letter to Henan Kangdi Medical Devices Co. Ltd. due to, among others, the failure to establish an adequate stability program. Furthermore, the quality unit was not provided with the appropriate authority and sufficient resources to carry out its responsibilities.

During an inspection carried out from 4 to 7 March, 2019, the FDA inspected the company's drug manufacturing facility in China. According to the FDA, the company failed to test finished products for strength and identity before releasing them into the U.S. market. Henan Kangdi Medical Devices Co. Ltd also failed to test incoming active pharmaceutical ingredients (API) and other raw materials used to manufacture the drug products to determine their identity, purity, strength, and other appropriate quality attributes. The stability program was also criticized. It was found that the company had not established an adequate stability program to support the expiration date assigned to the drug products.

Required Authority of the Quality Unit not given

The CGMP regulations specifically assign the quality unit the authority to create, monitor, and implement a quality system. Furthermore, the quality unit must be empowered to make final quality decisions. According to the FDA, the findings summarized in the warning letter indicate, however, that the company's quality unit is not fully exercising its authority and responsibilities.

All in all, the FDA comes to the conclusion that there is only a minimal assurance that the company's drug manufacturing operations are capable of operating in a state of control and placed the firm on Import Alert on October 25, 2019. Furthermore, the FDA strongly recommends engaging a GMP consultant to rectify the deficiencies. The consultant should perform a comprehensive audit of the company's entire operation for CGMP compliance and evaluate the completion and efficacy of the corrective actions and preventive actions.

The FDA has requested a response within 15 working days stating how the company will correct the violations. Failure to correct the violations may result in the FDA continuing to refuse admission of articles manufactured in the company's facility into the United States.

The original warning letter to Henan Kangdi Medical Devices Co. Ltd can be found on the FDA website.

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