FDA 483 - Chugai Pharma Manufacturing Co. Ltd. (CPMC) - August 23, 2021

Chugai Pharma Manufacturing Co., Ltd., Ukima Plant, a drug substance manufacturer in Kita-Ku, Tokyo, Japan, was cited with six observations during an FDA inspection. The observations primarily concern inadequate cleaning procedures and validation, insufficient data integrity controls for electronic systems, and deficiencies in following or establishing standard operating procedures. These issues indicate a lack of robust quality control and assurance in their manufacturing processes.