Company
BelgiumSurgical Instruments Belgium SA (SIBEL S.A.), Gembloux, Belgium – FDA Inspections
Inspection records and compliance data for Surgical Instruments Belgium SA (SIBEL S.A.) in Gembloux. 4 FDA inspections on record, 2 Form 483s, last inspected March 19, 2026.
Company Profile
This profile covers Surgical Instruments Belgium SA (SIBEL S.A.) based in Gembloux, Belgium.
FDA Inspection History
- FDA inspections
- 4
- OAI
- 0
- VAI
- 1
- NAI
- 1
- Unclassified
- 2
- Form 483s
- 2
- Warning letters
- 0
First inspected January 15, 2009. Last inspected March 19, 2026.
Most cited issue areas
- Corrective action not taken1 inspection
- Investigation of device failures1 inspection
- Lack of or inadequate procedures1 inspection
FDA inspections (4)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| March 19, 2026 | Not classified | Medical Devices & Rad Health · Compliance: Medical Devices | 1308024 |
| March 30, 2017 | Not classified | Medical Devices & Rad Health · Compliance: Devices | 1007295 |
| January 30, 2014 | VAI | Medical Devices & Rad Health · Compliance: Devices | 867438 |
| January 15, 2009 | NAI | Medical Devices & Rad Health · Compliance: Devices | 563773 |
FDA documents
Form 483s (1)
People (1)
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Company Information
Name
Surgical Instruments Belgium SA (SIBEL S.A.)
FEI Number
3003675041
Address
Rue Du Gaillard 5, Gembloux, Belgium
Country
Belgium
ID: 228b8d9f-c82a-43a0-b5a6-2f84f1871c76