FDA Inspection
Emory University Orthopaedics and Spine HospitalEmory University Orthopaedics and Spine Hospital – FDA Inspection, May 19, 2010
Record Details
This FDA Inspection record concerns Emory University Orthopaedics and Spine Hospital, with an inspection on May 19, 2010, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- May 19, 2010
- Product Type
- Biologics
View Company Profile
ID · 452a4a2d-266d-480e-81df-070907adf15c
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 664261
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
3- 21 CFR 1271.180(a)Procedures to meet core CTGP
- 21 CFR 1271.260(e)Storage temperatures recorded, maintained
- 21 CFR 1271.270(b)Prompt retrieval from multiple locations
Full citation text and observation details available on the Dashboard.
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 |
| March 7, 2012 | 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 772546 - 2012-03-07
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.