483
Kyowa Hakko Bio Co., Ltd.Kyowa Hakko Bio Co., Ltd. – FDA 483, Nov 8, 2019
Record Details
An FDA inspection of KYOWA HAKKO BIO CO., LTD. in Hofu-shi, Japan, an API manufacturer, revealed a significant failure to thoroughly review unexplained discrepancies. Specifically, the firm did not always perform adequate investigations into out-of-specification (OOS) results for microbial limits, lacking documented justifications for re-sampling and re-testing or failing to evaluate all potential root causes including cleaning validation.
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ID · 2b59b559-fc24-4243-abb8-b6ee8265f928
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