Overview
- 12 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-04-09.
At a glance
Inspections
12
Form 483s
3
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 17 Mar 2025 – 9 Apr 2025 | Medical Devices & Rad Health | Clean | |
| 1 Mar 2023 – 30 Mar 2023 | Medical Devices & Rad Health | Clean | |
| 25 May 2021 – 24 Jun 2021 | Medical Devices & Rad Health | WL | |
| 13 Jan 2020 – 31 Jan 2020 | Medical Devices & Rad Health | Clean | |
| 25 Feb 2019 – 8 Mar 2019 | Medical Devices & Rad Health | Clean | |
| 30 May 2017 – 16 Jun 2017 | Medical Devices & Rad Health | Clean | |
| 15 Jul 2015 – 9 Dec 2015 | Medical Devices & Rad Health | Clean | |
| 8 Aug 2011 | Not recorded | 483 | View 483 → |
| 17 Dec 2010 | Not recorded | 483 | View 483 → |
| 19 Dec 2008 | Not recorded | 483 | View 483 → |
| 18 Nov 2004 | Not recorded | Clean | |
| 25 Mar 2003 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
8 Aug 2011
21 CFR 820.30(g)
Design validation - Risk analysis
Cited by Rosanna M Goodrich, Benjamin J Dastoli, Leslie R Clark
8 Aug 2011
21 CFR 820.70(g)(1)
Maintenance schedule, Lack of or inadequate schedule
Cited by Rosanna M Goodrich, Benjamin J Dastoli, Leslie R Clark
8 Aug 2011
21 CFR 820.75(a)
Documentation
Cited by Rosanna M Goodrich, Benjamin J Dastoli, Leslie R Clark
8 Aug 2011
21 CFR 820.75(a)
Lack of or inadequate process validation
Cited by Rosanna M Goodrich, Benjamin J Dastoli, Leslie R Clark
8 Aug 2011
21 CFR 820.75(b)(2)
Documentation of validated process performance
Cited by Rosanna M Goodrich, Benjamin J Dastoli, Leslie R Clark
Investigators
FDA investigators tied to this site in the record.
Laureen M Geniusz6 insp.
Benjamin J Dastoli5 insp.
Rosanna M Goodrich3 insp.
Leslie R Clark2 insp.
Teresa K Kastner1 insp.
David J Gasparovich1 insp.
Katelyn A Staub-Zamperini1 insp.
Christina L Bigham1 insp.
John E Marszalek1 insp.
Cynthia T Cain1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.75(a) | Cited across public-safe Form 483 observations | 5x |
| 21 CFR 803.40(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.100(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.100(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.30(g) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.70(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.70(g)(1) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.90(b)(2) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 803.17(a)(3) | Cited across public-safe Form 483 observations | 1x |
| 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 806.10(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.160(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.198(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.22 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(f) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.70(i) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.75(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.75(b)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.80(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.86 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.90(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Invacare Corporation'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