FDA Inspection
Invacare CorporationInvacare Corporation – FDA Inspection, Dec 17, 2010
Record Details
This FDA Inspection record concerns Invacare Corporation, with an inspection on December 17, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Invacare Corporation
- Inspection Date
- December 17, 2010
- Product Type
- Devices
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ID · 6a282287-0aa8-4a71-8a6e-22af4b29f4b6
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 677839
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
13- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.160(a)Lack of or inadequate procedures for distribution
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.90(b)(2)Product rework procedures, Lack of or inadequate procedures
- 21 CFR 820.70(a)Process control procedures, Lack of or inadequate procedures
- 21 CFR 820.75(a)Documentation
- 21 CFR 820.70(a)Production processes
- 21 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate
- 21 CFR 820.70(g)(1)Maintenance schedule, Lack of or inadequate schedule
Showing 10 of 13 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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