Overview
- 4 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2016-04-28.
At a glance
Inspections
4
Form 483s
2
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 25 Apr 2016 – 28 Apr 2016 | Medical Devices & Rad Health | Clean | |
| 8 May 2013 – 14 May 2013 | Medical Devices & Rad Health | 483 | On file |
| 16 Aug 2012 | Not recorded | Clean | |
| 20 Jul 2009 | Not recorded | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
20 Jul 2009
21 CFR 820.25(b)
Training records
Cited by Connie Lucero, Eric C Behrens, Yvette S Montes, Luis A Salinas, Daniel Gill
20 Jul 2009
21 CFR 820.50(a)(3)
Acceptable supplier records
Cited by Connie Lucero, Eric C Behrens, Yvette S Montes, Luis A Salinas, Daniel Gill
Investigators
FDA investigators tied to this site in the record.
Camerson E Moore1 insp.
Akbar J Zaidi1 insp.
Cntrctmntr Rodriguez1 insp.
Connie Lucero1 insp.
Eric C Behrens1 insp.
Yvette S Montes1 insp.
Luis A Salinas1 insp.
Daniel Gill1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 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 |
Full site report
Get the verbatim findings behind GE Medical Systems Information Technologies' 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