FDA 483 - Chugai Pharma Manufacturing Co. Ltd. - February 21, 2020

Chugai Pharma Manufacturing Co. Ltd in Utsunomiya, Japan, a drug product manufacturer, was cited for significant deficiencies in its manufacturing processes. The inspection revealed failures to establish and follow appropriate procedures to prevent microbiological contamination of sterile drug products, specifically concerning aseptic and sterilization process validation. Additionally, the firm's test methods were found to be inadequately validated or verified.