644669
Children's Hospital Colorado — FEI 1771443
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- February 10, 2010
- Fiscal Year
- 2010
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Aurora, CO (United States)
Citations
| ID | CFR | Description |
|---|
| 154 | 21 CFR 606.160(a)(1) | Concurrent documentation |
| 155 | 21 CFR 606.160(b) | Required records |
| 158 | 21 CFR 606.160(e)(1) | Donor deferral record - each location |
| 160 | 21 CFR 606.160(a)(1) | Person performing, test results, interpretation |
| 208 | 21 CFR 640.3(a)(1) | Donor suitability procedures not followed |
| 227 | 21 CFR 640.4(h) | Storage temperatures after collection |
| 246 | 21 CFR 640.25(a) | Storage temps./agitation |
| 251 | 21 CFR 640.25(b) | Quality control |
| 31 | 21 CFR 606.20(b) | Qualifications of responsible personnel |
| 3244 | 21 CFR 640.61 | Written consent |
| 75 | 21 CFR 606.100(a) | SOP compliance |
| 76 | 21 CFR 606.100(b) | Establish, maintain and follow manufacturing SOPs |
| 77 | 21 CFR 606.100(b) | Written SOPs available for use by personnel |
| 89 | 21 CFR 606.100(b)(10) | Controlling storage temperatures |
| 9219 | 21 CFR 606.100(b)(20) | Donor deferral |
| 9271 | 21 CFR 610.41 | Donor Deferral - reentry |