FDA Inspection
Medtronic Spinal and BiologicsMedtronic Spinal and Biologics – FDA Inspection, Apr 9, 2009
Record Details
This FDA Inspection record concerns Medtronic Spinal and Biologics, with an inspection on April 9, 2009, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- April 9, 2009
- Product Type
- Biologics
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ID · e7a138f8-f4d6-4eef-89ee-fc8db1d2f882
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 573815
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
7- 21 CFR 1271.260(e)Temperature limits
- 21 CFR 1271.320(a)Procedures re complaints
- 21 CFR 1271.200(b)Procedures inadequate
- 21 CFR 1271.260(e)Periodic review of temperatures
- 21 CFR 1271.160(b)(1)Ensuring appropriate core requirements followed
- 21 CFR 1271.160(b)(2)Sharing of information (general)
- 21 CFR 1271.160(b)(2)(iii)Risk assessment, quarantine, recall, FDA
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Other FDA inspections of Medtronic Spinal and Biologics
2| Date | Classification | Office | Project area |
|---|---|---|---|
| March 14, 2014 | VAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| January 23, 2012 | VAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for Medtronic Spinal and Biologics
- FDA Inspection 869763 - 2014-03-14
- FDA Inspection 764267 - 2012-01-23
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