FDA Inspection
Spinal Integration, LLCSpinal Integration, LLC – FDA Inspection, Aug 20, 2009
Record Details
This FDA Inspection record concerns Spinal Integration, LLC, with an inspection on August 20, 2009, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Spinal Integration, LLC
- Inspection Date
- August 20, 2009
- Product Type
- Devices
View Company Profile
ID · 9b012f35-1a19-4632-9bd3-a791aefc2e6a
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 607571
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
4- 21 CFR 820.30(g)Design validation- Lack of or inadequate procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.50(b)Approval, inadequate purchasing data
- 21 CFR 820.30(j)Design history file
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Spinal Integration, LLC
1| Date | Classification | Office | Project area |
|---|---|---|---|
| October 19, 2012 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Spinal Integration, LLC
- FDA Inspection 803608 - 2012-10-19
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