# FDA 483 - Sterigenics U.S., LLC - December 17, 2024

Source: https://www.globalkeysolutions.net/records/483/sterigenics-us-llc/3a352343-ca21-4acb-bc9b-cb2cb4607f9c

> FDA 483 for Sterigenics U.S., LLC on December 17, 2024. Product: device. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Sterigenics U.S., LLC
- Inspection Date: 2024-12-17
- Product Type: device
- Office Name: Chicago District Office
- Summary: An FDA inspection of Sterigenics U.S., LLC in Schaumburg, IL, a medical device contract sterilization facility, revealed inadequacies in their corrective and preventive action (CAPA) procedures. The firm failed to perform retrospective reviews of nonconformances related to specific CAPAs, indicating a deficiency in their quality system. This suggests a moderate severity issue concerning the effectiveness of their CAPA process.

## Related Officers

- [Nicholas Z. Lu](https://www.globalkeysolutions.net/people/nicholas-z-lu/17448aca-e316-424c-b7b2-88c8baffc359)

Company: https://www.globalkeysolutions.net/companies/sterigenics-us-llc/474eaf62-290f-466d-8ec8-1255a2a26579

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