# FDA 483 - Isomedix Operations, Inc. - January 27, 2026

Source: https://www.keypedia.com/records/483/isomedix-operations-inc/bb4534f5-c4e7-4ae9-a690-ab833484a33a

> FDA 483 for Isomedix Operations, Inc. on January 27, 2026. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Isomedix Operations, Inc.
- Inspection Date: 2026-01-27
- Product Type: other
- Office Name: Chicago District Office
- Summary: An FDA inspection of Isomedix Operations, Inc. in Libertyville, IL, identified three significant observations related to the handling of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps). The firm failed to maintain records of HCT/P storage temperatures, lacked established procedures for HCT/P storage, and did not document preventative maintenance for equipment used in HCT/P storage. These deficiencies indicate a failure to meet current good tissue practice (CGTP) requirements.

## Related Documents

- [483 - 2023-09-18](https://www.keypedia.com/records/483/isomedix-operations-inc/8c7041a4-706e-4f89-b40f-3f4eb0eeaf27)
- [483 - 2023-09-18](https://www.keypedia.com/records/483/isomedix-operations-inc/9620b7a2-79dc-40b4-9e66-87d558713803)
- [483 - 2026-01-27](https://www.keypedia.com/records/483/isomedix-operations-inc/48078fae-beb3-4e38-a0ce-1a431c0c06b6)

## Related Officers

- [Gabryelle J. Solverud](https://www.keypedia.com/people/gabryelle-j-solverud/29c4452f-2f7a-4325-8f8d-7046fcb4690f)

Company: https://www.keypedia.com/companies/isomedix-operations-inc/a557725b-37c3-405c-bfbb-01da7749846c

Office: https://www.keypedia.com/offices/chicago-district-office/a510300b-0eaf-4a33-90b5-231d95977669