FDA Inspection
Elite Orthopaedics IncElite Orthopaedics Inc – FDA Inspection, Apr 29, 2015
Record Details
This FDA Inspection record concerns Elite Orthopaedics Inc, with an inspection on April 29, 2015, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Elite Orthopaedics Inc
- Inspection Date
- April 29, 2015
- Product Type
- Devices
View Company Profile
ID · 68a6e490-a374-4856-8f4e-046739100b84
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 924123
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
4- 21 CFR 820.20(c)Management review - Lack of or inadequate procedures
- 21 CFR 820.20(e)Quality System Procedures
- 21 CFR 820.20(b)Lack of or inadequate organizational structure
- 21 CFR 803.17Lack of Written MDR Procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Elite Orthopaedics Inc
1| Date | Classification | Office | Project area |
|---|---|---|---|
| April 1, 2010 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Elite Orthopaedics Inc
- FDA Inspection 655382 - 2010-04-01
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.