FDA Inspection
Surgical Instruments Belgium SA (SIBEL S.A.)Surgical Instruments Belgium SA (SIBEL S.A.) – FDA Inspection, Mar 30, 2017
Record Details
This FDA Inspection record concerns Surgical Instruments Belgium SA (SIBEL S.A.), with an inspection on March 30, 2017, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
- Inspection Date
- March 30, 2017
- Product Type
- Medical Devices & Rad Health
- Person
- Marc S. Neubauer (Issuing Officer)
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ID · 42df8669-4dd0-4fba-963e-91c79fc985d2
Inspection Facts
- Inspection number
- 1007295
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.70(i)Software validation for automated processes
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
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Other FDA inspections of Surgical Instruments Belgium SA (SIBEL S.A.)
3| Date | Classification | Office | Project area |
|---|---|---|---|
| March 19, 2026 | Not classified | Office of Inspections and Investigations | Compliance: Medical 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 1308024 - 2026-03-19
- FDA Inspection 867438 - 2014-01-30
- FDA Inspection 563773 - 2009-01-15
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