Sterigenics U.S., LLC – FDA 483, Aug 15, 2023

Sterigenics U.S., LLC in Rockaway, NJ, was inspected from August 8-15, 2023, and received a Form FDA-483 with four observations. The inspection revealed significant issues with process validation for gamma irradiation, inadequate corrective and preventive action procedures, and failures in equipment calibration and testing protocols. These findings indicate a need for improved quality system controls, particularly concerning sterilization processes and monitoring equipment.