716130
St. Mary's Regional Hospital — FEI 1770153
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 18, 2011
- Fiscal Year
- 2011
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Grand Junction, CO (United States)
Citations
| ID | CFR | Description |
|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 251 | 21 CFR 640.25(b) | Quality control |
| 253 | 21 CFR 640.25(b)(4) | Corrective action |
| 67 | 21 CFR 606.65(e) | Following manufacturer's instructions |
| 76 | 21 CFR 606.100(b) | Establish, maintain and follow manufacturing SOPs |
| 89 | 21 CFR 606.100(b)(10) | Controlling storage temperatures |
| 98 | 21 CFR 606.100(c) | Thorough investigations |