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

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.