FDA Inspection
SolTek Spine, LLC.SolTek Spine, LLC. – FDA Inspection, May 5, 2015
Record Details
This FDA Inspection record concerns SolTek Spine, LLC., with an inspection on May 5, 2015, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- SolTek Spine, LLC.
- Inspection Date
- May 5, 2015
- Product Type
- Biologics
View Company Profile
ID · 8398f1da-2839-4040-93cb-8aa7f5ec8f1d
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 924718
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
1- 21 CFR 1271.260(e)Storage temperatures recorded, maintained
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Other FDA inspections of SolTek Spine, LLC.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| June 28, 2012 | VAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for SolTek Spine, LLC.
- FDA Inspection 788375 - 2012-06-28
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