FDA 483 - Kyowa Hakko Bio Co., Ltd. - April 11, 2022

Kyowa Hakko Bio Co., Ltd. in Hofu-city, Japan, an API manufacturer, received a Form 483 with five observations. The inspection revealed significant deficiencies in the quality control unit's adherence to procedures, inadequate evaluation of change control impacts on API quality, insufficient water monitoring specifications, and inadequate laboratory and production system controls. These issues indicate a systemic lack of robust quality management and control.