FDA 483 - Sterigenics U.S. LLC - July 11, 2024

An FDA inspection of Sterigenics U.S., LLC in Mulberry, FL, revealed significant deficiencies in their quality system related to the sterilization of medical devices. Observations included a lack of adequate procedures for calibrating and maintaining dosimetry equipment, insufficient validation of production and quality system software, and failures in their corrective and preventive action processes. These issues raise concerns about the firm's ability to ensure the sterility and quality of medical devices.