FDA 483 - Sterigenics U.S., LLC - December 17, 2024

An FDA inspection of Sterigenics U.S., LLC in Schaumburg, IL, a medical device contract sterilization facility, revealed inadequacies in their corrective and preventive action (CAPA) procedures. The firm failed to perform retrospective reviews of nonconformances related to specific CAPAs, indicating a deficiency in their quality system. This suggests a moderate severity issue concerning the effectiveness of their CAPA process.