FDA Inspection
Surgical Instruments Belgium SA (SIBEL S.A.)Surgical Instruments Belgium SA (SIBEL S.A.) – FDA Inspection, Mar 19, 2026
Record Details
This FDA Inspection record concerns Surgical Instruments Belgium SA (SIBEL S.A.), with an inspection on March 19, 2026, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
- Inspection Date
- March 19, 2026
- Product Type
- Medical Devices & Rad Health
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ID · 89559ab1-0f57-43eb-a0ea-f4a70a4c594a
Inspection Facts
- Inspection number
- 1308024
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Medical Devices
FDA Citations
3- ISO 13485:2016 Clause 7.1Records of risk management activities in product realization not maintained
- ISO 13485:2016 Clause 7.5.6Planned results not consistently met during validation of processes
- ISO 13485:2016 Clause 8.5.2Corrective action not taken
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Other FDA inspections of Surgical Instruments Belgium SA (SIBEL S.A.)
3| Date | Classification | Office | Project area |
|---|---|---|---|
| March 30, 2017 | Not classified | Office of Inspections and Investigations | Compliance: Devices |
| January 30, 2014 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| January 15, 2009 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Surgical Instruments Belgium SA (SIBEL S.A.)
- FDA Inspection 1007295 - 2017-03-30
- FDA Inspection 867438 - 2014-01-30
- FDA Inspection 563773 - 2009-01-15
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