FDA 483 - Isomedix Operations, Inc - February 16, 2023

An FDA inspection of Isomedix Operations, Inc. in Chester, NY, a contract sterilizer, revealed two observations related to inadequate record-keeping and documentation. The firm was cited for issues with maintaining device history records, including incorrect calibration data and insufficient reviewer identification. Additionally, the inspection found inadequate documentation for major equipment used in a validated sterilization process.