753212
LifeSouth Community Blood Centers Inc — FEI 3003846669
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- November 14, 2011
- Fiscal Year
- 2012
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Madison, AL (United States)
Citations
| ID | CFR | Description |
|---|
| 154 | 21 CFR 606.160(a)(1) | Concurrent documentation |
| 155 | 21 CFR 606.160(b) | Required records |
| 163 | 21 CFR 606.165(b) | Distribution records - content |
| 236 | 21 CFR 640.5(e) | Testing - inspection |
| 238 | 21 CFR 640.11(a) | General requirements - storage |
| 241 | 21 CFR 640.11(b) | General requirements - inspection |
| 246 | 21 CFR 640.25(a) | Storage temps./agitation |
| 31 | 21 CFR 606.20(b) | Qualifications of responsible personnel |
| 61 | 21 CFR 606.60(a) | Provide proper equipment to meet requirements |
| 67 | 21 CFR 606.65(e) | Following manufacturer's instructions |
| 76 | 21 CFR 606.100(b) | Establish, maintain and follow manufacturing SOPs |
| 78 | 21 CFR 606.100(c) | Record review prior to release |
| 9078 | 21 CFR 600.12(a) | Maintenance - tracing |
| 9225 | 21 CFR 606.171 | Biological product deviation report |
| 98 | 21 CFR 606.100(c) | Thorough investigations |