FDA Inspection
Sterigenics Belgium Petit-Rechain S.A.Sterigenics Belgium Petit-Rechain S.A. – FDA Inspection, Jul 31, 2026
Record Details
This FDA Inspection record concerns Sterigenics Belgium Petit-Rechain S.A., with an inspection on July 31, 2026, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
- Inspection Date
- July 31, 2026
- Product Type
- Medical Devices & Rad Health
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ID · f3e52ffb-2d77-46f4-bcb5-a9e0d358d501
Inspection Facts
- Inspection number
- 1328738
- FDA center
- Medical Devices & Rad Health
- Project area
- Project Evaluation: Devices
- Outcome
- Form 483 issued
FDA Citations
2- ISO 13485:2016 Clause 7.1Records of risk management activities in product realization not maintained
- ISO 13485:2016 Clause 7.5.7Processes for sterilization and sterile barrier systems not validated
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Other FDA inspections of Sterigenics Belgium Petit-Rechain S.A.
7| Date | Classification | Office | Project area |
|---|---|---|---|
| June 29, 2023 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| January 18, 2023 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| February 10, 2016 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| September 16, 2014 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| March 27, 2014 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Sterigenics Belgium Petit-Rechain S.A.
- FDA Inspection 1232925 - 2023-06-29
- FDA Inspection 1195736 - 2023-01-18
- FDA Inspection 990052 - 2016-02-10
- FDA Inspection 897804 - 2014-09-16
- FDA Inspection 872473 - 2014-03-27
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