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

During an FDA inspection conducted from March 18 to March 29, 2024, Chugai Pharma Manufacturing Co., Ltd. (CPMC) at its Ukima plant in Tokyo, Japan, received several observations on a Form FDA 483, indicating deviations from regulatory standards for pharmaceutical manufacturing. Key issues included a significant risk of cross-contamination in drug substance operations due to shared viral filtration equipment and inadequate cleaning procedures for critical areas. The inspection also highlighted deficiencies in data integrity, specifically regarding the backup of electronic laboratory data, where IT personnel could delete files before secure cloud transfer. Procedural controls for production were found lacking, with insufficient guidance for operators on adding antifoam agents during bioreactor operations. Further observations noted inadequate adherence to or establishment of standard operating procedures, including issues with equipment time synchronization, incomplete instructions for cleaning dispensing equipment, and a deficient pest control program. Additionally, employee training assignments were not completed by their due dates. The facility also exhibited inadequate maintenance, evidenced by residue found in bioreactors post-cleaning. CPMC is expected to address these observations to ensure compliance with Current Good Manufacturing Practices.