Overview
- 8 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2023-11-17.
At a glance
Inspections
8
Form 483s
3
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 13 Nov 2023 – 17 Nov 2023 | Medical Devices & Rad Health | 483 | View 483 → |
| 28 Feb 2023 – 1 Mar 2023 | Medical Devices & Rad Health | Clean | |
| 25 Apr 2022 – 4 May 2022 | Medical Devices & Rad Health | Clean | |
| 30 Jul 2018 – 3 Aug 2018 | Medical Devices & Rad Health | Clean | |
| 20 Apr 2015 – 12 Jun 2015 | Medical Devices & Rad Health | 483 | On file |
| 28 Jan 2011 | Not recorded | 483 | On file |
| 30 Mar 2007 | Not recorded | Clean | |
| 1 Nov 2005 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
Investigators
FDA investigators tied to this site in the record.
Benjamin W Anderson2 insp.
Jennifer S Ness2 insp.
Albert L Nguyen1 insp.
Tyler R Courtney1 insp.
Emma R Schaefer1 insp.
Michelle J Glembin1 insp.
Susan M Matthias1 insp.
Corey K Reno1 insp.
Melissa J Holz1 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 | 1x |
Full site report
Get the verbatim findings behind Datex-Ohmeda, Inc.'s 3 Form 483s
Source PDFs 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