FDA 483 - Chugai Pharma Manufacturing Co. Ltd. - April 02, 2024

An FDA inspection of Chugai Pharma Manufacturing Co. Ltd. in Utsunomiya, Japan, a sterile drug manufacturer, revealed a significant deficiency in their aseptic processing. The firm's procedures for preventing microbial contamination of sterile drug products lacked adequate validation of the aseptic process, specifically concerning a smoke study that did not accurately simulate actual processing conditions. This issue impacts numerous vials of finished drug product released for commercial distribution in the U.S.