952024
UC Health Poudre Valley Hospital — FEI 1772751
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- November 30, 2015
- Fiscal Year
- 2016
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Fort Collins, CO (United States)
Citations
| ID | CFR | Description |
| 154 | 21 CFR 606.160(a)(1) | Concurrent documentation |
| 205 | 21 CFR 640.3(f) | Donations in less than eight weeks |
| 208 | 21 CFR 640.3(a)(1) | Donor suitability procedures not followed |
| 238 | 21 CFR 640.11(a) | General requirements - storage |
| 3245 | 21 CFR 640.61 | Explanation of hazards |
| 76 | 21 CFR 606.100(b) | Establish, maintain and follow manufacturing SOPs |