FDA Inspection
SpineSelect, LLCSpineSelect, LLC – FDA Inspection, May 15, 2013
Record Details
This FDA Inspection record concerns SpineSelect, LLC, with an inspection on May 15, 2013, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- SpineSelect, LLC
- Inspection Date
- May 15, 2013
- Product Type
- Devices
View Company Profile
ID · f6b69940-b0ee-4dea-9bd6-a2a7d96b9e8e
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 832623
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
3- 21 CFR 820.80(b)Incoming acceptance records, documentation
- 21 CFR 820.80(d)Lack of or inadequate final acceptance procedures
- 21 CFR 803.17Lack of Written MDR Procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of SpineSelect, LLC
1| Date | Classification | Office | Project area |
|---|---|---|---|
| September 10, 2010 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for SpineSelect, LLC
- FDA Inspection 678925 - 2010-09-10
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