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.