Overview
- 7 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2023-12-05.
At a glance
Inspections
7
Form 483s
3
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 20 Nov 2023 – 5 Dec 2023 | Medical Devices & Rad Health | 483 | View 483 → |
| 18 Nov 2019 – 20 Nov 2019 | Medical Devices & Rad Health | 483 | View 483 → |
| 16 Nov 2016 – 30 Nov 2016 | Medical Devices & Rad Health | Clean | |
| 8 Jul 2013 – 20 Aug 2013 | Medical Devices & Rad Health | 483 | View 483 → |
| 28 Feb 2011 | Not recorded | Clean | |
| 11 Mar 2009 | Not recorded | Clean | |
| 21 Jun 2007 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
Investigators
FDA investigators tied to this site in the record.
Brittani N Franklin1 insp.
Jesse A Vazquez1 insp.
That Q Dang1 insp.
Rafael Padilla1 insp.
Stefen D Mcmillan1 insp.
Joseph A Morkunas1 insp.
Stephen D Eich1 insp.
Paola S Barnett1 insp.
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 | 7x |
| 21 CFR 820.100(b) | Cited across public-safe Form 483 observations | 6x |
| 21 CFR 820.40(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.50 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.90(b)(2) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 803.17(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 803.17(b)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 803.50(a)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 803.56 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.120(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.181 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.184 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.198(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.22 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.25(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.50(a)(3) | 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 820.75(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.80(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.80(e) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Instrumed International Inc's 3 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