918262
The American National Red Cross - Southern Region — FEI 1073000
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 19, 2015
- Fiscal Year
- 2015
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Douglasville, GA (United States)
Citations
| ID | CFR | Description |
|---|
| 162 | 21 CFR 606.165(a) | Distribution and receipt - recalls |
| 181 | 21 CFR 610.53(b) | Dating periods for licensed biological products |
| 280 | 21 CFR 640.34(g)(1) | Final product - inspection |
| 31 | 21 CFR 606.20(b) | Qualifications of responsible personnel |
| 76 | 21 CFR 606.100(b) | Establish, maintain and follow manufacturing SOPs |
| 9076 | 21 CFR 600.12(a) | Maintenance - concurrence |
| 98 | 21 CFR 606.100(c) | Thorough investigations |