Overview
- 4 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2024-11-27.
At a glance
Inspections
4
Form 483s
3
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 14 Nov 2024 – 27 Nov 2024 | Medical Devices & Rad Health | Clean | |
| 6 Apr 2022 – 21 Apr 2022 | Medical Devices & Rad Health | 483 | On file |
| 20 Aug 2019 – 20 Sep 2019 | Medical Devices & Rad Health | WL | On file |
| 8 Apr 2013 – 12 Apr 2013 | Medical Devices & Rad Health | 483 | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
21 Apr 2022
21 CFR 803.50(a)(2)
Individual Report of Malfunction
Cited by Stephen C Smith
21 Apr 2022
21 CFR 803.50(a)(2)
Individual Report of Malfunction
Cited by Stephen C Smith
21 Apr 2022
21 CFR 820.30(g)
Design validation - software validation not performed
Cited by Stephen C Smith
21 Apr 2022
21 CFR 820.30(g)
Design validation - software validation not performed
Cited by Stephen C Smith
21 Apr 2022
21 CFR 803.50(a)(2)
Individual Report of Malfunction
Cited by Stephen C Smith
Investigators
FDA investigators tied to this site in the record.
Sunita Pandey1 insp.
Stephen C Smith1 insp.
Justine M Corson1 insp.
Matthew B Hazelett1 insp.
Maura Rooney1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 803.50(a)(2) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 820.30(g) | Cited across public-safe Form 483 observations | 4x |
Full site report
Get the verbatim findings behind Draeger Medical Systems, 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