FDA 483 - Isomedix Operations, Inc - November 04, 2019

Isomedix Operations, Inc, a contract sterilizer in Chester, NY, was cited for failing to document equipment checks during an FDA inspection. Specifically, the firm did not verify the error message functionality of its gamma irradiation dosage measurement equipment for out-of-range dosages, relying instead on incomplete manufacturer data. This indicates a lapse in quality control for critical sterilization processes.