FDA Emphasizes Importance of Quality Unit in Warning Letter

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The agency sent a warning letter to Henan Kangdi Medical Devices Co. Ltd after an inspection found CGMP violations that included a variety of failures of the company’s quality unit.

FDA sent a warning letter, dated Dec. 3, 2019, to Henan Kangdi Medical Devices Co. Ltd after an inspection of the company’s Zhoukou Shi Henan Sheng, China facility found violations of current good manufacturing practices (CGMP). The inspection was carried out from March 4–7, 2019.

In the letter, the agency stated the company did not test finished drug products for identity and strength before releasing product. The agency stated that the company’s quality unit must be provided with batch production and control records, including deviation and test data. “The quality unit must be empowered to make final quality decisions. It is essential that the quality unit be enabled to provide timely oversight of all laboratory and manufacturing data that could impact product quality, whether or not lots have already been distributed,” FDA stated.

The agency requested the company perform an independent review of its laboratory practices, procedures, equipment, and analysts. It also requested a summary of test results from retrospective testing of retain samples and a summary of its program for qualifying and overseeing contract facilities used to test products.

API and raw materials were also not properly tested, according to FDA, which the agency had cited the company for previously in December 2016. “You did not retain these suppliers' analysis reports, but discarded them after review. Additionally, you did not establish the reliability of your suppliers' analyses through appropriate validation. Your firm did not ensure that at least one specific identify test was conducted for each lot of your incoming materials,” the letter stated.

The agency requested the company provide an independent review to determine if materials obtained from suppliers were adequately qualified, provide quality control and testing specifications for incoming components, and provide a summary of test results obtained from testing all components from each manufacturer.


An adequate stability program was also not established, according to FDA. The company failed to assure that product had an expiration date supported by appropriate stability testing. “You lack sufficient data to demonstrate that the chemical and microbiological properties of your drug products will remain acceptable throughout their labeled expiry period,” the letter stated. The agency asked the company to provide a corrective action and preventive action plan to ensure the adequacy of it stability program; a program for designing, validating, maintaining, controlling, and monitoring processes and equipment; and an assurance the company’s top management will support quality control, quality assurance, and reliable operations.

The CGMP violations found during this and a previous inspection in December 2016 point to a problem with the company’s quality unit. “Significant findings in this letter indicate that your quality unit is not fully exercising its authority and/or responsibilities. Your firm must provide the quality unit with the appropriate authority and sufficient resources to carry out its responsibilities and consistently ensure drug quality,” FDA stated. Because of the observations found, FDA placed the firm on Import Alert 66-40 on October 25, 2019.

Source: FDA