FDA Inspection
Steel City Spine, IncSteel City Spine, Inc – FDA Inspection, Feb 2, 2012
Record Details
This FDA Inspection record concerns Steel City Spine, Inc, with an inspection on February 2, 2012, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- Steel City Spine, Inc
- Inspection Date
- February 2, 2012
- Product Type
- Biologics
View Company Profile
ID · 6eeee361-7b9a-4fb2-bd48-e643934763a1
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 765645
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
3- 21 CFR 1271.290(b)Establishing a system
- 21 CFR 1271.200(a)Capable of valid results
- 21 CFR 1271.160(b)(2)(iii)Risk assessment, quarantine, recall, FDA
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Other FDA inspections of Steel City Spine, Inc
1| Date | Classification | Office | Project area |
|---|---|---|---|
| December 21, 2009 | VAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
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