# FDA 483 - Isomedix Operations, Inc - December 12, 2024

Source: https://www.globalkeysolutions.net/records/483/isomedix-operations-inc/7b176d7b-f0cb-4072-af16-7e8956057c70

> FDA 483 for Isomedix Operations, Inc on December 12, 2024. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Isomedix Operations, Inc
- Inspection Date: 2024-12-12
- Product Type: device
- Office Name: New York District Office
- Summary: 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.

## Related Documents

- [483 - 2019-11-04](https://www.globalkeysolutions.net/records/483/isomedix-operations-inc/62ab3a34-e55a-414e-92ac-8e0decf9c5b1)
- [483 - 2023-02-16](https://www.globalkeysolutions.net/records/483/isomedix-operations-inc/7d76c9c6-38fd-4ea0-b83c-4f011ea24756)

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/kwong-p-lee/f4778925-1fad-4988-9e39-86482896c4fa)

Company: https://www.globalkeysolutions.net/companies/isomedix-operations-inc/759654d7-a6be-4f52-b899-d492d0527dbc

Office: https://www.globalkeysolutions.net/offices/new-york-district-office/9fa3d265-16ca-438d-8a6e-b47f60dc260d