Daito Kasei Kogyo Co Ltd – FDA Warning Letter, Jul 21, 2017

The FDA inspected Daito Kasei Kogyo Co., LTD., Okayama Factory, from July 18-21, 2017, identifying significant deviations from current good manufacturing practice (CGMP) for active pharmaceutical ingredients (API), rendering their API adulterated.

Key violations include: 1. **Failure to conduct appropriate laboratory tests:** The company released numerous drugs without completing all required identity and assay testing, despite claiming conformance to specifications. This posed risks of ineffective drugs and exposure to toxic impurities. The company's response, attributing this to a former QC manager's decision and lack of SOPs, was deemed inadequate for not detailing how data integrity would be ensured, who is responsible for testing, and how suitability of test methods would be assured. A risk assessment for distributed API with inaccurate COAs was also missing. 2. **Failure to completely report test results on certificates of analysis (COA):** The firm falsified COAs for API batches manufactured between June 2011 and February 2016, reporting results for tests (e.g., identity, impurities) that were never conducted. This compromises supply chain accountability and traceability. The company conducted a voluntary recall of affected API lots. Their explanation, citing no SOP for checking raw data before issuing COAs and a QC manager's decision to delete test columns, was inadequate for not identifying the extent of falsification or providing detailed corrective plans.

The FDA strongly recommends