Company
United KingdomSterigenics UK Limited, Alfreton, United Kingdom – FDA Inspections
Inspection records and compliance data for Sterigenics UK Limited in Alfreton. 4 FDA inspections on record, 1 Form 483, last inspected September 25, 2025.
Company Profile
This profile covers Sterigenics UK Limited based in Alfreton, United Kingdom.
FDA Inspection History
- FDA inspections
- 4
- OAI
- 0
- VAI
- 0
- NAI
- 3
- Unclassified
- 1
- Form 483s
- 1
- Warning letters
- 0
First inspected February 23, 2012. Last inspected September 25, 2025.
Most cited issue areas
- Documentation1 inspection
- Lack of or inadequate process validation1 inspection
- Management review - Lack of or inadequate procedures1 inspection
FDA inspections (4)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| September 25, 2025 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Medical Devices | 1284258 |
| December 15, 2022 | NAI | Medical Devices & Rad Health · Compliance: Devices | 1194568 |
| September 28, 2017 | Not classified | Medical Devices & Rad Health | 1031122 |
| February 23, 2012 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 773155 |
FDA documents
Form 483s (1)
People (1)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Sterigenics UK Limited
FEI Number
3002807091
Address
Cotes Park Estate, Alfreton, United Kingdom
Country
United Kingdom
ID: c716ef24-9e11-4b5a-9205-142e7e5f497d