FDA 483 - Sterigenics Radiation Technologies IN, Inc - September 19, 2024

An FDA inspection of Sterigenics Radiation Technologies IN, Inc. in Columbia City, IN, a contract sterilizer, identified two significant observations. The firm was cited for inadequate validation of a critical test method, lacking statistical rationale for established limits, and for deficiencies in their corrective and preventive action procedures, including an outdated pFMEA.