597360
St. Mary's Regional Hospital — FEI 1770153
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- May 11, 2009
- Fiscal Year
- 2009
- 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 |
| 160 | 21 CFR 606.160(a)(1) | Person performing, test results, interpretation |
| 333 | 21 CFR 640.64(e) | Prevention of contamination |
| 76 | 21 CFR 606.100(b) | Establish, maintain and follow manufacturing SOPs |
| 9235 | 21 CFR 630.40(c) | Documentation |
| 98 | 21 CFR 606.100(c) | Thorough investigations |