FDA Inspection 785217 — St. Luke's Magic Valley Medical Center
The FDA completed an inspection of St. Luke's Magic Valley Medical Center on April 26, 2012 in Twin Falls, ID. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- April 26, 2012
- Fiscal Year
- 2012
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Twin Falls, ID (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15030 | 21 CFR 606.60(b) | Equipment calibration frequency |
| 160 | 21 CFR 606.160(a)(1) | Person performing, test results, interpretation |
| 9077 | 21 CFR 600.12(a) | Maintenance - completeness |