Overview
- 14 FDA inspections are on record.
- 9 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-04-09.
At a glance
Inspections
14
Form 483s
9
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 17 Mar 2025 – 9 Apr 2025 | Medical Devices & Rad Health | 483 | View 483 → |
| 1 Mar 2023 – 30 Mar 2023 | Medical Devices & Rad Health | 483 | View 483 → |
| 25 May 2021 – 24 Jun 2021 | Medical Devices & Rad Health | WL | View 483 → |
| 13 Jan 2020 – 31 Jan 2020 | Medical Devices & Rad Health | 483 | View 483 → |
| 25 Feb 2019 – 8 Mar 2019 | Medical Devices & Rad Health | Clean | |
| 16 Oct 2017 – 26 Oct 2017 | Medical Devices & Rad Health | Clean | |
| 30 May 2017 – 16 Jun 2017 | Medical Devices & Rad Health | 483 | View 483 → |
| 16 Jul 2015 – 9 Dec 2015 | Medical Devices & Rad Health | 483 | View 483 → |
| 8 Aug 2011 | Not recorded | 483 | View 483 → |
| 17 Dec 2010 | Not recorded | 483 | View 483 → |
| 19 Dec 2008 | Not recorded | 483 | On file |
| 18 Nov 2004 | Not recorded | Clean | |
Observations on record
Form 483 observations cited at this site, most recent first.
9 Apr 2025
21 CFR 820.30(g)
Design Validation - Risk analysis not performed/inadequate
Cited by Rosanna M Goodrich
9 Apr 2025
21 CFR 820.50(a)(3)
Acceptable supplier records, inadequate records
Cited by Rosanna M Goodrich
30 Mar 2023
21 CFR 820.30(g)
Design Validation - Risk analysis not performed/inadequate
Cited by Laureen M Geniusz, Benjamin J Dastoli
30 Mar 2023
21 CFR 820.50
Purchasing controls, Lack of or inadequate procedures
Cited by Laureen M Geniusz, Benjamin J Dastoli
Investigators
FDA investigators tied to this site in the record.
Laureen M Geniusz7 insp.
Benjamin J Dastoli6 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 820.198(a) | Cited across public-safe Form 483 observations | 5x |
| 21 CFR 820.30(g) | Cited across public-safe Form 483 observations | 5x |
| 21 CFR 820.50 | Cited across public-safe Form 483 observations | 5x |
| 21 CFR 820.100(b) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 820.100(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.30(c) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.30(f) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.30(i) | 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 803.50(a)(2) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.198(c) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.25(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.30(d) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.40(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 803.17 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 803.40(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.198(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.250(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.250(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.40 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.50(a)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.75(a) | 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(d) | Cited across public-safe Form 483 observations | 1x |
| n/a | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Invacare Corporation's 9 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