FDA Inspection
Steel City Spine, IncSteel City Spine, Inc – FDA Inspection, Dec 21, 2009
Record Details
This FDA Inspection record concerns Steel City Spine, Inc, with an inspection on December 21, 2009, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- Steel City Spine, Inc
- Inspection Date
- December 21, 2009
- Product Type
- Biologics
View Company Profile
ID · f098b7f7-e68b-447d-becb-f1e814af1c11
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 634830
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
6- 21 CFR 1271.160(a)Program is appropriate for the HCT/Ps
- 21 CFR 1271.290(b)Establishing a system
- 21 CFR 1271.160(c)Quality audits performed periodically
- 21 CFR 1271.170(c)Trained or re-trained as necessary
- 21 CFR 1271.180(b)Review and approval-responsible person
- 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 |
|---|---|---|---|
| February 2, 2012 | VAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
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