Overview
- 6 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2014-07-25.
At a glance
Inspections
6
Form 483s
3
EIRs
1
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 21 Jul 2014 – 25 Jul 2014 | Human Drugs | 483 | View 483 → |
| 20 Aug 2012 | Not recorded | 483 | View 483 → |
| 21 Jul 2010 | Not recorded | Clean | |
| 22 Feb 2010 | Not recorded | Clean | |
| 15 Oct 2009 | Not recorded | 483 | On file |
| 15 Jun 2006 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
25 Jul 2014
21 CFR 314.80(b)
Failure to develop written procedures
Cited by Russell J Glapion, Marcia Gelber
Investigators
FDA investigators tied to this site in the record.
Russell J Glapion1 insp.
Marcia Gelber1 insp.
Justine Tomasso1 insp.
Frederick Razzaghi1 insp.
Addam S Reynolds1 insp.
Doreen P Gubbay1 insp.
Dawn L Wydner1 insp.
Dorothy J Denes1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 314.80(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.198(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind GE Healthcare, 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