Overview
- 10 FDA inspections are on record.
- 4 inspections produced a Form 483.
- The most recent recorded inspection date is 2023-08-17.
At a glance
Inspections
10
Form 483s
4
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 7 Aug 2023 – 17 Aug 2023 | Medical Devices & Rad Health | Clean | |
| 8 Jun 2021 – 29 Jun 2021 | Medical Devices & Rad Health | Clean | |
| 12 Jun 2018 – 22 Jun 2018 | Medical Devices & Rad Health | 483 | On file |
| 2 Mar 2015 – 25 Mar 2015 | Medical Devices & Rad Health | 483 | View 483 → |
| 28 Sep 2011 | Not recorded | Clean | |
| 21 Nov 2008 | Not recorded | 483 | View 483 → |
| 22 Feb 2008 | Not recorded | 483 | On file |
| 29 Aug 2006 | Not recorded | Clean | |
| 1 Dec 2004 | Not recorded | Clean | |
| 7 Apr 2000 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
25 Mar 2015
21 CFR 820.100(a)
Lack of or inadequate procedures
Cited by James R Montero, Ashleigh P Wodushek
25 Mar 2015
21 CFR 820.198(c)
Investigation of device failures
Cited by James R Montero, Ashleigh P Wodushek
25 Mar 2015
21 CFR 820.100(a)
Lack of or inadequate procedures
Cited by James R Montero, Ashleigh P Wodushek
25 Mar 2015
21 CFR 820.198(c)
Investigation of device failures
Cited by James R Montero, Ashleigh P Wodushek
21 Nov 2008
21 CFR 803.18(e)
MDR not evaluated per 820.162 and 820.198
Cited by Nathan R Moon, Bryan J Love
Investigators
FDA investigators tied to this site in the record.
James R Montero4 insp.
Nathan R Moon2 insp.
Nancy Bogdanovic1 insp.
Rebecca L Stephany1 insp.
Vicky L Cruz1 insp.
Phillip M Pontikos1 insp.
Ashleigh P Wodushek1 insp.
Daniel J Lahar1 insp.
Linda F Murphy1 insp.
Janet Pulver1 insp.
Bryan J Love1 insp.
Thai T Duong1 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 | 2x |
| 21 CFR 820.198(c) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 803.18(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.100(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(a)(4) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.180 | 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 |
Full site report
Get the verbatim findings behind GE OEC Medical Systems, Inc'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