Kyowa Hakko Bio Co., Ltd.November 8, 2019

FDA 483 - Kyowa Hakko Bio Co., Ltd. - November 08, 2019

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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.

Company: Kyowa Hakko Bio Co., Ltd.
Inspection Date: November 8, 2019
Product Type: Drugs
Office: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
People: Sneha Patel
Margaret M. Annes

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ID · 2b59b559-fc24-4243-abb8-b6ee8265f928