FDA Inspection
Tissue Bank International/The National Eye Bank CenterTissue Bank International/The National Eye Bank Center – FDA Inspection, Jun 20, 2012
Record Details
This FDA Inspection record concerns Tissue Bank International/The National Eye Bank Center, with an inspection on June 20, 2012, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- June 20, 2012
- Product Type
- Biologics
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ID · 9952de3e-c1d7-4258-b6f3-3c4382e51835
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 788443
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
5- 21 CFR 1271.260(e)Temperature limits
- 21 CFR 1271.195(c)Monitoring-microorganisms where appropriate
- 21 CFR 1271.180(a)Procedures to meet core CTGP
- 21 CFR 1271.260(e)Storage temperatures recorded, maintained
- 21 CFR 1271.230(b)Reduced risk representation
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Other FDA inspections of Tissue Bank International/The National Eye Bank Center
2| Date | Classification | Office | Project area |
|---|---|---|---|
| September 4, 2013 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| August 27, 2010 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for Tissue Bank International/The National Eye Bank Center
- FDA Inspection 847161 - 2013-09-04
- FDA Inspection 681527 - 2010-08-27
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