Overview
- 8 FDA inspections are on record.
- 7 inspections produced a Form 483.
- The most recent recorded inspection date is 2020-01-06.
At a glance
Inspections
8
Form 483s
7
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 2 Jan 2020 – 6 Jan 2020 | Medical Devices & Rad Health | 483 | View 483 → |
| 24 May 2016 – 27 May 2016 | Medical Devices & Rad Health | 483 | View 483 → |
| 24 Apr 2014 – 25 Apr 2014 | Medical Devices & Rad Health | 483 | View 483 → |
| 21 Sep 2012 | Not recorded | Clean | |
| 20 Jul 2012 | Not recorded | 483 | View 483 → |
| 21 Jan 2010 | Not recorded | 483 | View 483 → |
| 10 Mar 2009 | Not recorded | 483 | On file |
| 23 May 2008 | Not recorded | 483 | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
Investigators
FDA investigators tied to this site in the record.
Sharon I Gundersen2 insp.
James A Lane1 insp.
Paul M Kawamoto1 insp.
Kun C Liu1 insp.
Stephen R Souza1 insp.
Maria P Kelly-Doggett1 insp.
Heika R Tait1 insp.
S. L Brown1 insp.
Catherine J Laufmann1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.198(a) | Cited across public-safe Form 483 observations | 6x |
| 21 CFR 820.100(a) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 820.72(a) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 820.50 | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.25(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.40(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.50(a)(1) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.90(b)(1) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.198(b)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.42(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(i) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.40 | 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 Gynex Corporation's 7 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