Company
BelgiumSterigenics Belgium Petit-Rechain S.A., Petit-Rechain, Belgium – FDA Inspections
Inspection records and compliance data for Sterigenics Belgium Petit-Rechain S.A. in Petit-Rechain. 8 FDA inspections on record, 1 Form 483, last inspected July 31, 2026.
Company Profile
This profile covers Sterigenics Belgium Petit-Rechain S.A. based in Petit-Rechain, Belgium.
FDA Inspection History
- FDA inspections
- 8
- OAI
- 0
- VAI
- 1
- NAI
- 6
- Unclassified
- 1
- Form 483s
- 1
- Warning letters
- 0
First inspected November 11, 2010. Last inspected July 31, 2026.
Most cited issue areas
- Processes for sterilization and sterile barrier systems not validated1 inspection
- Records of risk management activities in product realization not maintained1 inspection
FDA inspections (8)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| July 31, 2026 | Not classified | Medical Devices & Rad Health · Project Evaluation: Devices | 1328738 |
| June 29, 2023 | VAI | Human Drugs · Drug Quality Assurance | 1232925 |
| January 18, 2023 | NAI | Medical Devices & Rad Health · Compliance: Devices | 1195736 |
| February 10, 2016 | NAI | Human Drugs · Drug Quality Assurance | 990052 |
| September 16, 2014 | NAI | Human Drugs · Drug Quality Assurance | 897804 |
| March 27, 2014 | NAI | Medical Devices & Rad Health · Compliance: Devices | 872473 |
| February 6, 2013 | NAI | Medical Devices & Rad Health · Compliance: Devices | 817224 |
| November 11, 2010 | NAI | Medical Devices & Rad Health · Bioresearch Monitoring | 699599 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Sterigenics Belgium Petit-Rechain S.A.
FEI Number
3002807111
Address
Zoning Industriel De Petit-rechain, Avenue Andre Ernst 21, Petit-Rechain, Belgium
Country
Belgium
ID: dbfccd17-4f8c-42ad-8616-9fdf022cd954