FDA Inspection 664261 — Emory University Orthopaedics And Spine Hospital
The FDA completed an inspection of Emory University Orthopaedics And Spine Hospital on May 19, 2010 in Tucker, GA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 3 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- May 19, 2010
- Fiscal Year
- 2010
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Tucker, GA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12336 | 21 CFR 1271.180(a) | Procedures to meet core CTGP |
| 12416 | 21 CFR 1271.260(e) | Storage temperatures recorded, maintained |
| 12440 | 21 CFR 1271.270(b) | Prompt retrieval from multiple locations |