750971
Banco de Sangre de Servicios Mutuos, Inc. — FEI 2677485
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- October 19, 2011
- Fiscal Year
- 2012
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- San Juan, PR (United States)
Citations
| ID | CFR | Description |
| 106 | 21 CFR 606.120(a) | Separation of labeling operations |
| 154 | 21 CFR 606.160(a)(1) | Concurrent documentation |
| 157 | 21 CFR 606.160(d) | Retention period |
| 76 | 21 CFR 606.100(b) | Establish, maintain and follow manufacturing SOPs |
| 9077 | 21 CFR 600.12(a) | Maintenance - completeness |
| 98 | 21 CFR 606.100(c) | Thorough investigations |