FDA Inspection 1010331 — Emory University Hospital Midtown- Center for Transfusion & Cellular Therapies
The FDA completed an inspection of Emory University Hospital Midtown- Center for Transfusion & Cellular Therapies on April 28, 2017 in Atlanta, GA. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 2 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- April 28, 2017
- Fiscal Year
- 2017
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Atlanta, GA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15046 | 21 CFR 610.47(b)(3) | Timeframe for Notification of Transfusion Recips [Consignee] |
| 76 | 21 CFR 606.100(b) | Establish, maintain and follow manufacturing SOPs |