764488
Intermountain Health Saint Joseph Hospital — FEI 1771639
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- January 26, 2012
- Fiscal Year
- 2012
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Denver, 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 |
| 76 | 21 CFR 606.100(b) | Establish, maintain and follow manufacturing SOPs |
| 78 | 21 CFR 606.100(c) | Record review prior to release |
| 89 | 21 CFR 606.100(b)(10) | Controlling storage temperatures |
| 9235 | 21 CFR 630.40(c) | Documentation |