FDA Inspection
Invacare CorporationInvacare Corporation – FDA Inspection, Aug 18, 2010
Record Details
This FDA Inspection record concerns Invacare Corporation, with an inspection on August 18, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Invacare Corporation
- Inspection Date
- August 18, 2010
- Product Type
- Devices
View Company Profile
ID · acc17b71-94fd-4f1c-9e03-41974f99bacd
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 677464
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Enforcement
- 483 Response
FDA Citations
6- 21 CFR 820.198(c)Investigation of device failures
- 21 CFR 820.100(b)Documentation
- 21 CFR 820.30(g)Design validation - user needs and intended uses
- 21 CFR 820.25(a)Personnel
- 21 CFR 820.50(a)Evaluation of suppliers, contractors, etc., requirements
- 21 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Invacare Corporation
4| Date | Classification | Office | Project area |
|---|---|---|---|
| November 27, 2017 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| October 20, 2014 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| July 27, 2011 | OAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| February 9, 2009 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Invacare Corporation
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.