FDA Inspection 743406 — University Of Colorado Hospital Clinical Laboratory
The FDA completed an inspection of University Of Colorado Hospital Clinical Laboratory on August 30, 2011 in Aurora, CO. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 21 citations were issued during this inspection. Product area: Biologics.
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 |