Overview
- 9 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2022-08-15.
At a glance
Inspections
9
Form 483s
3
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 11 Aug 2022 – 15 Aug 2022 | Medical Devices & Rad Health | Clean | |
| 25 Jun 2013 – 3 Jul 2013 | Medical Devices & Rad Health | 483 | View 483 → |
| 9 Jul 2009 | Not recorded | 483 | View 483 → |
| 12 Feb 2009 | Not recorded | Clean | |
| 2 Jun 2008 | Not recorded | 483 | On file |
| 8 Sep 2005 | Not recorded | Clean | |
| 24 Sep 2004 | Not recorded | Clean | |
| 28 Feb 2002 | Not recorded | Clean | |
| 30 Nov 1999 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
9 Jul 2009
21 CFR 803.50(a)(1)
Report of Death or Serious Injury
Cited by James M Odonnell, Norman Wong
9 Jul 2009
21 CFR 820.100(a)(3)
Identification of actions needed
Cited by James M Odonnell, Norman Wong
Investigators
FDA investigators tied to this site in the record.
Michael J Nerz3 insp.
Michelle L Johnson1 insp.
Brian S Keefer1 insp.
James M Odonnell1 insp.
Norman Wong1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 803.50(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 803.50(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(b) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Draeger Medical Systems, 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