Overview
- 15 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-09-19.
At a glance
Inspections
15
Form 483s
3
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 15 Sep 2025 – 19 Sep 2025 | Human Drugs | Clean | |
| 27 Feb 2024 – 8 Mar 2024 | Human Drugs | 483 | View 483 → |
| 25 Sep 2023 – 2 Oct 2023 | Human Drugs | Clean | |
| 8 Jan 2020 – 24 Jan 2020 | Human Drugs | Clean | |
| 6 Sep 2017 | Medical Devices & Rad Health | Clean | |
| 17 Feb 2015 – 5 Mar 2015 | Medical Devices & Rad Health | Clean | |
| 17 Feb 2015 – 4 Mar 2015 | Medical Devices & Rad Health | Clean | |
| 27 Jun 2013 – 9 Jul 2013 | Medical Devices & Rad Health | Clean | |
| 13 Feb 2012 | Not recorded | Clean | |
| 8 Apr 2010 | Not recorded | 483 | View 483 → |
| 2 Jul 2009 | Not recorded | Clean | |
| 25 Jun 2008 | Not recorded | 483 | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
8 Mar 2024
21 CFR 312.50
Ensuring compliance with plan and protocol
Cited by Kent A Conforti, Meredith L Miller
8 Apr 2010
21 CFR 211.110(a)
Control procedures to monitor and validate performance
Cited by Carrie-Ann Plucinski
Investigators
FDA investigators tied to this site in the record.
Christopher D Leach3 insp.
Russell K Riley2 insp.
Carrie-Ann Plucinski2 insp.
Sangeeta M Khurana1 insp.
Kent A Conforti1 insp.
Meredith L Miller1 insp.
Nibin Varghese1 insp.
Brian D Nicholson1 insp.
Stephen D Eich1 insp.
Bruce H Mccullough1 insp.
Debra I Love1 insp.
James W Plucinski1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.110(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.194(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 312.50 | 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