743406
University Of Colorado Hospital Clinical Laboratory — FEI 3003233482
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- August 30, 2011
- Fiscal Year
- 2011
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Aurora, CO (United States)
Citations
| ID | CFR | Description |
|---|
| 1270 | 21 CFR 211.68(b) | input/output verification |
| 1274 | 21 CFR 211.68(a) | Calibration/Inspection/Checking not done |
| 15030 | 21 CFR 606.60(b) | Equipment calibration frequency |
| 154 | 21 CFR 606.160(a)(1) | Concurrent documentation |
| 155 | 21 CFR 606.160(b) | Required records |
| 160 | 21 CFR 606.160(a)(1) | Person performing, test results, interpretation |
| 161 | 21 CFR 606.160(a)(2) | Determination of lot numbers and supplies |
| 205 | 21 CFR 640.3(f) | Donations in less than eight weeks |
| 215 | 21 CFR 640.3(b)(6) | Qualifications of donor - disease transmissible by blood |
| 218 | 21 CFR 640.3(c)(2) | History of viral hepatitis - close contact |
| 236 | 21 CFR 640.5(e) | Testing - inspection |
| 251 | 21 CFR 640.25(b) | Quality control |
| 31 | 21 CFR 606.20(b) | Qualifications of responsible personnel |
| 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 |
| 80 | 21 CFR 606.100(b)(1) | Donor criteria |
| 9219 | 21 CFR 606.100(b)(20) | Donor deferral |
| 9264 | 21 CFR 610.40(d)(4) | Autologous donation - label |
| 9288 | 21 CFR 640.21(a) | Eligibility of platelet donors |
| 98 | 21 CFR 606.100(c) | Thorough investigations |