1016453
U.S. Navy Medicine Readiness and Training Command Rota Spain — FEI 3002809467
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- May 17, 2017
- Fiscal Year
- 2017
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Rota (Spain)
Citations
| ID | CFR | Description |
|---|
| 113 | 21 CFR 606.121(b) | Collection/initial processing facility labels |
| 137 | 21 CFR 606.121(c)(13) | Unapproved encoded/machine readable information |
| 154 | 21 CFR 606.160(a)(1) | Concurrent documentation |
| 31 | 21 CFR 606.20(b) | Qualifications of responsible personnel |
| 76 | 21 CFR 606.100(b) | Establish, maintain and follow manufacturing SOPs |