# FDA 483 - Isomedix Operations Inc. - April 12, 2022

Source: https://www.globalkeysolutions.net/records/483/isomedix-operations-inc/903ea820-b74d-453f-8dc5-ea7f209abfbe

> FDA 483 for Isomedix Operations Inc. on April 12, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Isomedix Operations Inc.
- Inspection Date: 2022-04-12
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: During an inspection, Isomedix Operations Inc. in Chester, NY, an E-Beam Contract Sterilizer, was cited for inadequate procedures to control nonconforming product. The firm failed to issue nonconformity reports for out-of-specification E-beam dose verifications and allowed customers to incorrectly complete nonconformity reports with missing or conflicting final dispositions. These issues indicate a significant breakdown in quality control processes for irradiated products.

## Related Documents

- [483 - 2019-11-07](https://www.globalkeysolutions.net/records/483/isomedix-operations-inc/6444098d-f926-430d-90df-9f5ba6c37dc2)

## Related Officers

- [Jacqueline S. Warner](https://www.globalkeysolutions.net/people/jacqueline-s-warner/d001f4ec-db46-4d78-a5dd-efea7ddfb893)

Company: https://www.globalkeysolutions.net/companies/isomedix-operations-inc/0c78fec2-88ae-46ae-b5c4-cecffb9fdc50

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