483
Isomedix Operations, IncFDA 483 - Isomedix Operations, Inc - December 12, 2024
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Record Details
Isomedix Operations, Inc. in Chester, NY, a medical device sterilizer, was inspected by the FDA. The inspection revealed a significant issue with the maintenance of device history records, specifically regarding illegible information in a dose mapping validation record. This indicates a moderate severity finding related to record-keeping practices.
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ID · 7b176d7b-f0cb-4072-af16-7e8956057c70