FDA Inspection
Spinal Solutions, LLCSpinal Solutions, LLC – FDA Inspection, Sep 15, 2011
Record Details
This FDA Inspection record concerns Spinal Solutions, LLC, with an inspection on September 15, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Spinal Solutions, LLC
- Inspection Date
- September 15, 2011
- Product Type
- Devices
View Company Profile
ID · 37342ad2-1d46-4a89-bbdc-d271b6cfd198
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 737718
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
16- 21 CFR 820.181DMR - not or inadequately maintained
- 21 CFR 820.160(b)Distribution records
- 21 CFR 820.40(a)Document review, approval by designated individual
- 21 CFR 820.20(c)Management review - defined interval, sufficient frequency
- 21 CFR 820.80(b)Lack of or inadequate receiving acceptance procedures
- 21 CFR 820.80(d)Lack of or inadequate final acceptance procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.150Lack of or inadequate procedures for storage.
- 21 CFR 820.25(b)Training - Lack of or inadequate procedures
- 21 CFR 820.120Lack of or inadequate procedures for labeling
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Other FDA inspections of Spinal Solutions, LLC
1| Date | Classification | Office | Project area |
|---|---|---|---|
| September 11, 2012 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
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