Overview
- 7 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2024-05-30.
At a glance
Inspections
7
Form 483s
2
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 23 May 2024 – 30 May 2024 | Medical Devices & Rad Health | Clean | |
| 1 Aug 2022 – 17 Aug 2022 | Medical Devices & Rad Health | 483 | View 483 → |
| 28 Jul 2021 – 25 Aug 2021 | Medical Devices & Rad Health | WL | View 483 → |
| 27 Jan 2016 – 28 Jan 2016 | Medical Devices & Rad Health | Clean | |
| 22 Feb 2012 | Not recorded | Clean | |
| 31 Mar 2010 | Not recorded | Clean | |
| 15 Apr 2009 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
17 Aug 2022
21 CFR 820.198(a)
Lack of or inadequate complaint procedures
Cited by Dennis R Hock, Lindsey L Kirsh
17 Aug 2022
21 CFR 820.30(f)
Design verification - output does not meet input requirement
Cited by Dennis R Hock, Lindsey L Kirsh
Investigators
FDA investigators tied to this site in the record.
Dennis R Hock4 insp.
James M Odonnell2 insp.
Lindsey L Kirsh1 insp.
Katelyn A Staub-Zamperini1 insp.
Erica L Nicoll1 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 | 3x |
| 21 CFR 820.198(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.30(f) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 803.17(a)(1) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 803.50(a)(1) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.198(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.198(e) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.30(g) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.90(b)(2) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.198(c) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind DeVilbiss Healthcare LLC's 2 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