780127
Children's Hospital Colorado — FEI 1771443
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- May 15, 2012
- Fiscal Year
- 2012
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Aurora, CO (United States)
Citations
| ID | CFR | Description |
|---|
| 142 | 21 CFR 606.140(a) | Establishment of spec., standards, and test procedures |
| 144 | 21 CFR 606.140(c) | Adequate identification and handling of test samples |
| 15030 | 21 CFR 606.60(b) | Equipment calibration frequency |
| 160 | 21 CFR 606.160(a)(1) | Person performing, test results, interpretation |
| 208 | 21 CFR 640.3(a)(1) | Donor suitability procedures not followed |
| 67 | 21 CFR 606.65(e) | Following manufacturer's instructions |
| 76 | 21 CFR 606.100(b) | Establish, maintain and follow manufacturing SOPs |
| 89 | 21 CFR 606.100(b)(10) | Controlling storage temperatures |
| 9220 | 21 CFR 606.100(b)(21) | Donor notification |
| 9235 | 21 CFR 630.40(c) | Documentation |
| 9596 | 21 CFR 640.3(a) | Donor suitability by means of medical history |