Overview
- 5 FDA inspections are on record.
- 4 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-02-19.
At a glance
Inspections
5
Form 483s
4
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 16 Feb 2026 – 19 Feb 2026 | Medical Devices & Rad Health | Clean | |
| 7 Nov 2022 – 10 Nov 2022 | Medical Devices & Rad Health | 483 | View 483 → |
| 8 Jul 2019 – 11 Jul 2019 | Medical Devices & Rad Health | 483 | View 483 → |
| 7 May 2018 – 11 May 2018 | Medical Devices & Rad Health | WL | On file |
| 3 Feb 2014 – 6 Feb 2014 | Medical Devices & Rad Health | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
10 Nov 2022
21 CFR 820.20(c)
Management review - Lack of or inadequate procedures
Cited by Nydia E Colon
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 820.100(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.184 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.20(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.20(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(g) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.70(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Boule Medical AB'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