FDA Inspection
Emory University Orthopaedics and Spine HospitalEmory University Orthopaedics and Spine Hospital – FDA Inspection, Mar 7, 2012
Record Details
This FDA Inspection record concerns Emory University Orthopaedics and Spine Hospital, with an inspection on March 7, 2012, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- March 7, 2012
- Product Type
- Biologics
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ID · 44206e11-9a85-452e-9cda-593049f19645
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 772546
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
6- 21 CFR 1271.290(b)Establishing a system
- 21 CFR 1271.290(c)Identification code
- 21 CFR 1271.160(b)(6)Deviations--evaluation, cause, corrective action
- 21 CFR 1271.260(e)Storage temperatures recorded, maintained
- 21 CFR 1271.160(b)(1)Ensuring appropriate core requirements followed
- 21 CFR 1271.290(c)Relating new code to old code
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Other FDA inspections of Emory University Orthopaedics and Spine Hospital
5| Date | Classification | Office | Project area |
|---|---|---|---|
| July 14, 2022 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| October 31, 2018 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| December 8, 2016 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| December 12, 2014 | VAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| May 19, 2010 | VAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for Emory University Orthopaedics and Spine Hospital
- FDA Inspection 1175108 - 2022-07-14
- FDA Inspection 1072637 - 2018-10-31
- FDA Inspection 996119 - 2016-12-08
- FDA Inspection 906325 - 2014-12-12
- FDA Inspection 664261 - 2010-05-19
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