# FDA 483 - Sterigenics UK Limited - September 25, 2025

Source: https://www.keypedia.com/records/483/sterigenics-uk-limited/7923e036-5b2c-4b84-867a-d7584b598aec

> FDA 483 for Sterigenics UK Limited on September 25, 2025. Product: other. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Sterigenics UK Limited
- Inspection Date: 2025-09-25
- Product Type: other
- Office Name: Office of Medical Device and Radiological Health Operations
- Summary: An FDA inspection of Sterigenics UK Limited, a contract sterilizer in Alfreton, revealed significant quality system deficiencies. The firm failed to adequately validate a process change for nitrogen pressure in sterilization chambers and did not properly document corrective actions for temperature control issues in an aeration room. Additionally, the company's management review procedures were not followed, as key managers were absent from a required review meeting.

## Related Officers

- [Frank J. Marciniak](https://www.keypedia.com/people/frank-j-marciniak/6995351a-6afc-4056-9692-d4aeb711dd92)

Company: https://www.keypedia.com/companies/sterigenics-uk-limited/c716ef24-9e11-4b5a-9205-142e7e5f497d

Office: https://www.keypedia.com/offices/office-of-medical-device-and-radiological-health-operations/27658190-735a-443e-9087-3534cfe74fd4