896777
Mountain View Hospital, LLC — FEI 3006102925
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- September 10, 2014
- Fiscal Year
- 2014
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Idaho Falls, ID (United States)
Citations
| ID | CFR | Description |
|---|
| 15030 | 21 CFR 606.60(b) | Equipment calibration frequency |
| 154 | 21 CFR 606.160(a)(1) | Concurrent documentation |
| 31 | 21 CFR 606.20(b) | Qualifications of responsible personnel |
| 67 | 21 CFR 606.65(e) | Following manufacturer's instructions |
| 76 | 21 CFR 606.100(b) | Establish, maintain and follow manufacturing SOPs |
| 94 | 21 CFR 606.100(b)(15) | Schedules and procedures for equipment & calibration |
| 98 | 21 CFR 606.100(c) | Thorough investigations |