# FDA 483 - Isomedix Operations Inc - July 25, 2022

Source: https://www.keypedia.com/records/483/isomedix-operations-inc/dd981783-1601-4090-801f-18d96d5221ba

> FDA 483 for Isomedix Operations Inc on July 25, 2022. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Isomedix Operations Inc
- Inspection Date: 2022-07-25
- Product Type: other
- Office Name: Cincinnati District Office
- Summary: 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.

## Related Officers

- [investigator](https://www.keypedia.com/people/javonica-f-penn/56294265-08fc-4d1d-8a34-626fc4dad457)

Company: https://www.keypedia.com/companies/isomedix-operations-inc/2e07a0b3-1a95-443d-8dad-87169998d288

Office: https://www.keypedia.com/offices/cincinnati-district-office/b67a0c35-82e3-4176-9039-988378f65c22