# FDA 483 - Isomedix Operations, Inc. - September 18, 2023

Source: https://www.keypedia.com/records/483/isomedix-operations-inc/9620b7a2-79dc-40b4-9e66-87d558713803

> FDA 483 for Isomedix Operations, Inc. on September 18, 2023. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Isomedix Operations, Inc.
- Inspection Date: 2023-09-18
- Product Type: other
- Office Name: Division of Human and Animal Food Operations - East VI
- Summary: Isomedix Operations Inc. in Libertyville, IL, a radiation sterilization facility, was cited for significant quality control and production process deficiencies during an FDA inspection. Observations included the improper discarding of original processing records, failure to define operational qualification intervals and perform periodic verification for gamma irradiators, and a lack of control over the issuance of electronic processing records. Additionally, the firm failed to adequately extend investigations into discrepancies, specifically regarding the use of expired verification dosimeters and their impact on released drug products.

## Related Officers

- [Roshni J. Patel](https://www.keypedia.com/people/roshni-j-patel/362827f6-562d-4780-b641-9c4bf0e1097b)
- [Nibin Varghese](https://www.keypedia.com/people/nibin-varghese/43e17f63-2c1f-4d46-b26f-dc8ac8885438)

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

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-east-vi/4a1cadca-f04c-44d0-8d7a-4e1d6e583766