FDA Inspection 772546 — Emory University Orthopaedics And Spine Hospital
The FDA completed an inspection of Emory University Orthopaedics And Spine Hospital on Mar 7, 2012 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). 6 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Mar 7, 2012
- Fiscal Year
- 2012
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Tucker, GA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12311 | 21 CFR 1271.160(b)(1) | Ensuring appropriate core requirements followed |
| 12325 | 21 CFR 1271.160(b)(6) | Deviations--evaluation, cause, corrective action |
| 12416 | 21 CFR 1271.260(e) | Storage temperatures recorded, maintained |
| 12447 | 21 CFR 1271.290(b) | Establishing a system |
| 12448 | 21 CFR 1271.290(c) | Identification code |
| 12451 | 21 CFR 1271.290(c) | Relating new code to old code |