FDA Inspection
Medtronic Spinal and BiologicsMedtronic Spinal and Biologics – FDA Inspection, Mar 14, 2014
Record Details
This FDA Inspection record concerns Medtronic Spinal and Biologics, with an inspection on March 14, 2014, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- March 14, 2014
- Product Type
- Biologics
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ID · 0e176bf3-1e5a-4219-833e-9fe44ec2955b
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 869763
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
2- 21 CFR 1271.290(b)Establishing a system
- 21 CFR 1271.160(b)(6)Deviations--Investigation, documenting, trending
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Other FDA inspections of Medtronic Spinal and Biologics
2| Date | Classification | Office | Project area |
|---|---|---|---|
| January 23, 2012 | VAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| April 9, 2009 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for Medtronic Spinal and Biologics
- FDA Inspection 764267 - 2012-01-23
- FDA Inspection 573815 - 2009-04-09
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