FDA Inspection
Invacare CorporationInvacare Corporation – FDA Inspection, Dec 19, 2008
Record Details
This FDA Inspection record concerns Invacare Corporation, with an inspection on December 19, 2008, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Invacare Corporation
- Inspection Date
- December 19, 2008
- Product Type
- Devices
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ID · f3334e0d-6dd5-4c8f-af51-4d3d66a184ed
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 546628
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
11- 21 CFR 803.50(a)(2)Individual Report of Malfunction
- 21 CFR 803.50(a)(1)Report of Death or Serious Injury
- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 806.10(b)Time to report - 10 days
- 21 CFR 820.100(b)Documentation
- 21 CFR 820.30(f)Design verification - Lack of or inadequate procedures
- 21 CFR 820.30(a)Design control - no procedures
- 21 CFR 820.75(b)Lack/Inad procedure-Monitoring/Control of Validated Proces
- 21 CFR 820.22Quality Audit/Reaudit - conducted
- 21 CFR 803.40(a)Report of death, injury
Showing 10 of 11 citations.
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Other FDA inspections of Invacare Corporation
9| Date | Classification | Office | Project area |
|---|---|---|---|
| April 9, 2025 | Not classified | Cincinnati District Office | |
| March 30, 2023 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| June 24, 2021 | OAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| January 31, 2020 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| March 8, 2019 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Invacare Corporation
- FDA Inspection 1268238 - 2025-04-09
- FDA Inspection 1203095 - 2023-03-30
- FDA Inspection 1147199 - 2021-06-24
- FDA Inspection 1118985 - 2020-01-31
- FDA Inspection 1085712 - 2019-03-08
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