678411
UC Health Poudre Valley Hospital — FEI 1772751
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- August 19, 2010
- Fiscal Year
- 2010
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Fort Collins, CO (United States)
Citations
| ID | CFR | Description |
|---|
| 158 | 21 CFR 606.160(e)(1) | Donor deferral record - each location |
| 4425 | 21 CFR 606.60(a) | Equipment observed, standardized, calibrated |
| 67 | 21 CFR 606.65(e) | Following manufacturer's instructions |
| 76 | 21 CFR 606.100(b) | Establish, maintain and follow manufacturing SOPs |
| 9225 | 21 CFR 606.171 | Biological product deviation report |
| 98 | 21 CFR 606.100(c) | Thorough investigations |