FDAnews Drug Daily Bulletin
Pharmaceuticals / Inspections and Audits

Japanese Drugmaker Draws FDA Warning for Repeat Offenses

Aug. 23, 2018

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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