# FDA 483 - Isomedix Operations, Inc - February 16, 2023

Source: https://www.globalkeysolutions.net/records/483/isomedix-operations-inc/7d76c9c6-38fd-4ea0-b83c-4f011ea24756

> FDA 483 for Isomedix Operations, Inc on February 16, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Isomedix Operations, Inc
- Inspection Date: 2023-02-16
- Product Type: device
- Office Name: New York District Office
- Summary: An FDA inspection of Isomedix Operations, Inc. in Chester, NY, a contract sterilizer, revealed two observations related to inadequate record-keeping and documentation. The firm was cited for issues with maintaining device history records, including incorrect calibration data and insufficient reviewer identification. Additionally, the inspection found inadequate documentation for major equipment used in a validated sterilization process.

## Related Documents

- [483 - 2019-11-04](https://www.globalkeysolutions.net/records/483/isomedix-operations-inc/62ab3a34-e55a-414e-92ac-8e0decf9c5b1)
- [483 - 2024-12-12](https://www.globalkeysolutions.net/records/483/isomedix-operations-inc/7b176d7b-f0cb-4072-af16-7e8956057c70)

## 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