Overview
- 6 FDA inspections are on record.
- 4 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-03-19.
At a glance
Inspections
6
Form 483s
4
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 16 Mar 2026 – 19 Mar 2026 | Medical Devices & Rad Health | 483 | View 483 → |
| 7 Nov 2022 – 10 Nov 2022 | Medical Devices & Rad Health | 483 | View 483 → |
| 27 Mar 2017 – 30 Mar 2017 | Medical Devices & Rad Health | 483 | View 483 → |
| 27 Jan 2014 – 30 Jan 2014 | Medical Devices & Rad Health | 483 | View 483 → |
| 15 Jan 2009 | Not recorded | Clean | |
| 15 Mar 2007 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
19 Mar 2026
ISO 13485:2016 Clause 7.1
Records of risk management activities in product realization not maintained
Cited by Stephen D Eich
19 Mar 2026
ISO 13485:2016 Clause 7.5.6
Planned results not consistently met during validation of processes
Cited by Stephen D Eich
Investigators
FDA investigators tied to this site in the record.
Stephen D Eich1 insp.
Melanie W Pishnery1 insp.
Marc S Neubauer1 insp.
Maryam Tabatabaie1 insp.
Richard J Tucker1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.90(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.100(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.100(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.184 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.198(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.250(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.40 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.50(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.70(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.70(i) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.75(a) | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 7.1 | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 7.5.6 | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 8.5.2 | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Surgical Instruments Belgium SA (SIBEL S.A.)'s 4 Form 483s
Verbatim observations and recurring CFR citations, so your team knows what this site gets cited for.
- The site's full inspection history, with every Form 483 and its outcome
- Warning letters and recalls tied to the company behind it
- Whether recurring CFR citations get closed out or repeat