Overview
- 7 FDA inspections are on record.
- 6 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-03-18.
At a glance
Inspections
7
Form 483s
6
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 11 Mar 2025 – 18 Mar 2025 | Medical Devices & Rad Health | 483 | View 483 → |
| 3 Nov 2022 – 7 Nov 2022 | Medical Devices & Rad Health | 483 | View 483 → |
| 16 May 2016 – 20 May 2016 | Medical Devices & Rad Health | WL | View 483 → |
| 18 Feb 2015 – 20 Feb 2015 | Medical Devices & Rad Health | WL | View 483 → |
| 19 Aug 2013 – 21 Aug 2013 | Medical Devices & Rad Health | 483 | View 483 → |
| 18 Feb 2010 | Not recorded | Clean | |
| 5 Dec 2008 | Not recorded | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
18 Mar 2025
21 CFR 820.90(a)
Nonconforming product, Lack of or inadequate procedures
Cited by Marvin A Marenco
Investigators
FDA investigators tied to this site in the record.
Richard K Vogel2 insp.
Marvin A Marenco1 insp.
Ashley A Mutawakkil1 insp.
Karen M Rodriguez1 insp.
Melanie W Pishnery1 insp.
Melanie G Warzala1 insp.
Althea A Williams1 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 | 5x |
| 21 CFR 820.198(a) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 820.100(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.50(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.25(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.30(f) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.30(g) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 801.20(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.100(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.198(e)(6) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.20(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.50 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.75(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.90(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Stat Medical Devices, Inc.'s 6 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