483
Isomedix Operations IncIsomedix Operations Inc – FDA 483, Jul 25, 2022
Record Details
Isomedix Operations Inc, a manufacturer and contract sterilizer in Groveport, OH, was cited for failing to validate processes during an FDA inspection. The firm lacked evidence of completed validation activities for critical equipment used in processing and failed to conduct required periodic assessments. This indicates a significant lapse in ensuring processes are adequately controlled and verified.
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ID · dd981783-1601-4090-801f-18d96d5221ba
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