# FDA 483 - Sterigenics U.S., LLC - August 15, 2023

Source: https://www.keypedia.com/records/483/sterigenics-us-llc/70f353d9-3a93-432d-a959-f243b1c8cf30

> FDA 483 for Sterigenics U.S., LLC on August 15, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Sterigenics U.S., LLC
- Inspection Date: 2023-08-15
- Product Type: device
- Office Name: New Jersey District Office
- Summary: Sterigenics U.S., LLC in Rockaway, NJ, was inspected from August 8-15, 2023, and received a Form FDA-483 with four observations. The inspection revealed significant issues with process validation for gamma irradiation, inadequate corrective and preventive action procedures, and failures in equipment calibration and testing protocols. These findings indicate a need for improved quality system controls, particularly concerning sterilization processes and monitoring equipment.

## Related Officers

- [Colin E. Tack](https://www.keypedia.com/people/colin-e-tack/5bdbf977-d4ac-48fe-81cc-ada89379ed0d)

Company: https://www.keypedia.com/companies/sterigenics-us-llc/bb2ed1d7-f397-44d3-ba4a-7f0ae5ae49b1

Office: https://www.keypedia.com/offices/new-jersey-district-office/6ff5e2e9-5cff-44c7-af24-5a55329a8248