761340
UC Health Poudre Valley Hospital — FEI 1772751
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- December 14, 2011
- Fiscal Year
- 2012
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Fort Collins, CO (United States)
Citations
| ID | CFR | Description |
|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1274 | 21 CFR 211.68(a) | Calibration/Inspection/Checking not done |
| 158 | 21 CFR 606.160(e)(1) | Donor deferral record - each location |
| 160 | 21 CFR 606.160(a)(1) | Person performing, test results, interpretation |
| 227 | 21 CFR 640.4(h) | Storage temperatures after collection |
| 238 | 21 CFR 640.11(a) | General requirements - storage |
| 255 | 21 CFR 640.31 | Donor eligibility |
| 3245 | 21 CFR 640.61 | Explanation of hazards |
| 376 | 21 CFR 640.120 | Alternative procedures |
| 4576 | 21 CFR 211.192 | No written record of investigation |
| 61 | 21 CFR 606.60(a) | Provide proper equipment to meet requirements |
| 76 | 21 CFR 606.100(b) | Establish, maintain and follow manufacturing SOPs |
| 9243 | 21 CFR 630.40(a) | Notification |
| 98 | 21 CFR 606.100(c) | Thorough investigations |