# FDA 483 - Isomedix Operations, Inc - November 04, 2019

Source: https://www.keypedia.com/records/483/isomedix-operations-inc/62ab3a34-e55a-414e-92ac-8e0decf9c5b1

> FDA 483 for Isomedix Operations, Inc on November 04, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Isomedix Operations, Inc
- Inspection Date: 2019-11-04
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: Isomedix Operations, Inc, a contract sterilizer in Chester, NY, was cited for failing to document equipment checks during an FDA inspection. Specifically, the firm did not verify the error message functionality of its gamma irradiation dosage measurement equipment for out-of-range dosages, relying instead on incomplete manufacturer data. This indicates a lapse in quality control for critical sterilization processes.

## Related Documents

- [483 - 2023-02-16](https://www.keypedia.com/records/483/isomedix-operations-inc/7d76c9c6-38fd-4ea0-b83c-4f011ea24756)
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## Related Officers

- [Gregson A Joseph](https://www.keypedia.com/people/gregson-a-joseph/90bf8118-3f32-4f44-95c4-fcde1f741a18)
- [Eric C. Schmitt](https://www.keypedia.com/people/eric-c-schmitt/f2716c8c-f06e-4519-a1e7-63a3ef6e07fb)

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

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-east-i/a807f00e-d780-40b8-b233-1eb92ece8961