FDA 483 - Chugai Pharma Manufacturing Co. Ltd. - September 01, 2017

An FDA inspection of Chugai Pharma Manufacturing Co., Ltd. in Utsunomiya City, Japan, revealed several significant deficiencies in their manufacturing and quality control processes. Observations included inadequate smoke studies for filling lines, insufficient quality assurance oversight, and failures in deviation management. The firm also had issues with the validation of its electronic Manufacturing Execution System and non-compliance with pest control procedures.