FDA 483 - Sterigenics UK Limited - September 25, 2025

An FDA inspection of Sterigenics UK Limited, a contract sterilizer in Alfreton, revealed significant quality system deficiencies. The firm failed to adequately validate a process change for nitrogen pressure in sterilization chambers and did not properly document corrective actions for temperature control issues in an aeration room. Additionally, the company's management review procedures were not followed, as key managers were absent from a required review meeting.