FDA Inspection
Renegade Wheelchairs, LLCRenegade Wheelchairs, LLC – FDA Inspection, Aug 26, 2016
Record Details
This FDA Inspection record concerns Renegade Wheelchairs, LLC, with an inspection on August 26, 2016, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Renegade Wheelchairs, LLC
- Inspection Date
- August 26, 2016
- Product Type
- Devices
View Company Profile
ID · 260a60c8-53e9-4242-841d-a33d063b66d8
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 982928
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
4- 21 CFR 820.40Lack of procedures, or not maintained
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.22Quality Audit/Reaudit - conducted
- 21 CFR 803.17Lack of Written MDR Procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Renegade Wheelchairs, LLC
2| Date | Classification | Office | Project area |
|---|---|---|---|
| June 4, 2012 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| January 7, 2010 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Renegade Wheelchairs, LLC
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.