FDA 483 - Kyowa Chemical Industry Co., Ltd. - March 29, 2019

Kyowa Chemical Industry Co., Ltd. in Sakaide, Japan, an API manufacturer, was cited for significant data integrity and facility control deficiencies during an FDA inspection. Observations included a lack of oversight for QC laboratory systems, inadequate data backup and verification, and unrestricted access to raw material and finished product warehouses and production areas. These issues indicate a serious breakdown in quality control and security protocols.