# FDA 483 - Sterigenics US LLC - May 31, 2023

Source: https://www.keypedia.com/records/483/sterigenics-us-llc/2d9087ec-cdee-4cc2-bbae-ce5bd2f7f8ea

> FDA 483 for Sterigenics US LLC on May 31, 2023. Product: other. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Sterigenics US LLC
- Inspection Date: 2023-05-31
- Product Type: other
- Office Name: New Jersey District Office
- Summary: An FDA inspection of Sterigenics US LLC in Salem, NJ, revealed significant deficiencies in their quality system. The firm failed to adequately establish corrective and preventive action procedures, validate processes whose results cannot be fully verified, and maintain device history records in accordance with device master records. These issues indicate a lack of robust quality control over their manufacturing operations.

## Related Officers

- [Frank J. Marciniak](https://www.keypedia.com/people/frank-j-marciniak/6995351a-6afc-4056-9692-d4aeb711dd92)
- [Shirley S. Wen](https://www.keypedia.com/people/shirley-s-wen/eafbc8e5-a0ac-443a-adaf-ced505f77842)

Company: https://www.keypedia.com/companies/sterigenics-us-llc/a9d88ec8-d5ad-4db7-8ea0-ed649886aaf8

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