FDA Inspection
Surgical Instruments Belgium SA (SIBEL S.A.)Surgical Instruments Belgium SA (SIBEL S.A.) – FDA Inspection, Jan 30, 2014
Record Details
This FDA Inspection record concerns Surgical Instruments Belgium SA (SIBEL S.A.), with an inspection on January 30, 2014, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- January 30, 2014
- Product Type
- Devices
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ID · a4a9ac58-75b3-464e-9b83-ec72f294842c
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 867438
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
4- 21 CFR 820.198(c)Investigation of device failures
- 21 CFR 820.40Procedures not adequately established or maintained
- 21 CFR 820.250(b)Sampling plans
- 21 CFR 820.50(b)Supplier notification of changes
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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 |
| March 30, 2017 | Not classified | Office of Inspections and Investigations | 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 1007295 - 2017-03-30
- FDA Inspection 563773 - 2009-01-15
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