FDA Issues Warning Letter to Japanese API Manufacturer

The US Food and Drug Administration (FDA) has issued a Warning Letter to Daito Kasei Kogyo, an Osaka, Japan-headquartered active pharmaceutical ingredient (API) manufacturer, for deviations from current good manufacturing practices for active pharmaceutical ingredients (APIs). This follows an inspection by the FDA of the company’s drug manufacturing facility in Okayama, Japan from July 18 to 21, 2017.

Specifically, the FDA cited the company for failure to ensure that, for each batch of API, appropriate laboratory tests were conducted to determine conformance to specifications. The agency said that the company failed to confirm data, who is responsible for conducting tests, and how the company intended to ensure the integrity of this data. The agency also said that the company failed to conduct a risk assessment on the effects of the lack of release testing on the quality of drugs it distributed. The agency said that the company released numerous drugs without completing all required testing.

In response to the letter, the FDA requested that the company provide:

  • A detailed description of how it plans to test each component for conformity with all appropriate written specifications for identity, purity, strength, and quality;
  • A detailed description of how it plans to test bulk API to determine conformance to specifications;
  • A detailed explanation of who will conduct raw material and finished API testing and how it plans to assure the suitability of test methods and the reliability of test results; and
  • A risk assessment for any API within the re-test date and distributed within the US that were released with inaccurate certificate of analysis.

The FDA also cited the company for failure to completely report test results on certificates of analysis. The agency says the company falsified the certificates of analysis issued to its customers by reporting the results of identity and impurities tests that it never conducted.

Based upon the nature of the deviations the FDA identified at the firm, the agency recommended that the company engage a consultant qualified to evaluate the company’s operations and assist the firm in meeting cGMP requirements. The FDA also said the company’s quality system does not adequately ensure the accuracy and integrity of data to support the safety, effectiveness, and quality of the drugs it manufactures. The FDA recommended that the firm retain a qualified consultant to assist in its remediation.

In response to the letter, the FDA asked that the company provide:

  • A comprehensive investigation into the extent of the inaccuracies in data records and reporting;
  • A current risk assessment of the potential effects of the observed failures on the quality of its drugs. Its assessment should include analyses of the risks to patients caused by the release of drugs affected by a lapse of data integrity, and risks posed by ongoing operations; and
  • A management strategy for the firm that includes the details of its global corrective action and preventive action plan.

Source: FDA

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