Overview
- 4 FDA inspections are on record.
- 4 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-04-02.
At a glance
Inspections
4
Form 483s
4
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 30 Mar 2026 – 2 Apr 2026 | Medical Devices & Rad Health | 483 | View 483 → |
| 7 Nov 2022 – 10 Nov 2022 | Medical Devices & Rad Health | 483 | View 483 → |
| 14 May 2018 – 17 May 2018 | Medical Devices & Rad Health | 483 | View 483 → |
| 16 Feb 2015 – 19 Feb 2015 | Medical Devices & Rad Health | 483 | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
2 Apr 2026
ISO 13485:2016 Clause 4.2.4
Document Control Procedure Inadequate
Cited by David J Gasparovich
2 Apr 2026
ISO 13485:2016 Clause 7.5.1
Production and service provision not adequate
Cited by David J Gasparovich
2 Apr 2026
ISO 13485:2016 Clause 7.5.6
Procedures for validation of processes lack required elements
Cited by David J Gasparovich
2 Apr 2026
ISO 13485:2016 Clause 7.6
Procedures for monitoring and measuring equipment requirements not documented
Cited by David J Gasparovich
Investigators
FDA investigators tied to this site in the record.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.22 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.20(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.70(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.90(a) | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 4.2.4 | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 7.5.1 | 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 7.6 | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Orfit Industries NV's 4 Form 483s
Source PDFs, 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