Overview
- 5 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2023-04-05.
At a glance
Inspections
5
Form 483s
2
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 4 Apr 2023 – 5 Apr 2023 | Medical Devices & Rad Health | Clean | |
| 16 Mar 2020 – 17 Mar 2020 | Medical Devices & Rad Health | Clean | |
| 8 Nov 2016 – 10 Nov 2016 | Medical Devices & Rad Health | Clean | |
| 17 Jul 2013 – 25 Jul 2013 | Medical Devices & Rad Health | 483 | View 483 → |
| 26 May 2009 | Not recorded | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
25 Jul 2013
21 CFR 820.30(g)
Design validation- Lack of or inadequate procedures
Cited by Kirtida Patel
Investigators
FDA investigators tied to this site in the record.
Alexandria L Capuano1 insp.
Angelica G Aziz1 insp.
Bryan A Galvez1 insp.
Vickie L Anderson1 insp.
Kirtida Patel1 insp.
Mark E Chan1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 803.50(a)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.100(a)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.100(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.198(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(g) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.80(d) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Vertos Medical, Inc.'s 2 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