FDA Inspection
Invacare CorporationInvacare Corporation – FDA Inspection, Aug 8, 2011
Record Details
This FDA Inspection record concerns Invacare Corporation, with an inspection on August 8, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Invacare Corporation
- Inspection Date
- August 8, 2011
- Product Type
- Devices
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ID · e9789f2f-be8e-4b46-a6e1-95793a697b30
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 738716
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
9- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.90(b)(2)Product rework procedures, Lack of or inadequate procedures
- 21 CFR 820.80(c)Lack of or inadequate In-process acceptance procedures
- 21 CFR 820.75(a)Documentation
- 21 CFR 820.90(a)Nonconforming product control
- 21 CFR 820.30(g)Design validation - Risk analysis
- 21 CFR 820.70(g)(1)Maintenance schedule, Lack of or inadequate schedule
- 21 CFR 820.75(b)(2)Documentation of validated process performance
Full citation text and observation details available on the Dashboard.
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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