FDA Inspection 650590 — North Colorado Medical Center Blood Bank
The FDA completed an inspection of North Colorado Medical Center Blood Bank on Feb 24, 2010 in Greeley, CO. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 8 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Feb 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 |