Daiichi Sankyo Chemical Pharma Co., Ltd. – FDA 483, Nov 8, 2019

An FDA inspection of Daiichi Sankyo Chemical Pharma Co., Ltd.'s Onahama Plant, a drug substance manufacturer, revealed five observations. The findings primarily concerned deficiencies in quality unit approval of procedures, inadequate environmental monitoring, insufficient disinfectant efficacy studies, and scientifically unjustified equipment qualifications. These issues indicate a need for improved quality system controls and validation practices.