650590
North Colorado Medical Center Blood Bank — FEI 1774110
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- February 24, 2010
- Fiscal Year
- 2010
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Greeley, CO (United States)
Citations
| ID | CFR | Description |
|---|
| 143 | 21 CFR 606.140(b) | Provisions to monitor lab test procedures & instruments |
| 155 | 21 CFR 606.160(b) | Required records |
| 162 | 21 CFR 606.165(a) | Distribution and receipt - recalls |
| 1787 | 21 CFR 211.80(a) | Procedures To Be in Writing |
| 1890 | 21 CFR 211.165(e) | Test methods |
| 251 | 21 CFR 640.25(b) | Quality control |
| 4413 | 21 CFR 211.194(a)(8) | Second person sign off |
| 76 | 21 CFR 606.100(b) | Establish, maintain and follow manufacturing SOPs |