FDA 483 - Chugai Pharma Manufacturing Co. Ltd. (CPMC) - March 29, 2024

Chugai Pharma Manufacturing Co., Ltd. (CPMC) in Tokyo, Japan, a drug substance manufacturer, was cited with five observations during an FDA inspection. The findings highlight significant concerns including risks of viral cross-contamination in drug substance manufacturing, inadequate protection of laboratory electronic data, and deficiencies in written production and process control procedures. Additionally, the inspection revealed issues with adherence to standard operating procedures, pest control, employee training, and overall facility maintenance, indicating a need for comprehensive corrective actions to ensure product quality and compliance.