FDA 483 - Chugai Pharma Manufacturing Co. Ltd. - September 26, 2019

An FDA inspection of Chugai Pharma Manufacturing Co. Ltd. in Utsunomiya, Japan, revealed significant deficiencies in laboratory controls, production systems, and quality control. Repeat observations from previous inspections highlight ongoing issues with data integrity, electronic record management, and the adequacy of visual inspection processes for finished drug products. The firm also failed to adequately investigate product complaints and deviations, indicating a systemic breakdown in quality oversight.