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Pharmaceuticals / Inspections and Audits

Japanese Drugmaker Draws FDA Warning for Repeat Offenses

Aug. 23, 2018
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Citing data integrity concerns, the FDA hit Kyowa Hakka Bio with another warning letter for repeat violations at its Hofu, Yamaguchi facility. The agency issued a previous warning to the facility in 2010.

The FDA said the API manufacturer used data or performed retesting after obtaining out-of-specification results. The facility also manipulated data to meet a system suitability test’s specifications for high-performance liquid chromatography (HPLC) analysis of raw material.

The firm cited a “lack of awareness” of the good manufacturing deviations and an environment that allowed for easy manipulation of test data.

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