FDA Inspection 1019446 — Asante Rogue Regional Medical Center
The FDA completed an inspection of Asante Rogue Regional Medical Center on July 27, 2017 in Medford, OR. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- July 27, 2017
- Fiscal Year
- 2017
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Medford, OR (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15030 | 21 CFR 606.60(b) | Equipment calibration frequency |
| 4425 | 21 CFR 606.60(a) | Equipment observed, standardized, calibrated |
| 67 | 21 CFR 606.65(e) | Following manufacturer's instructions |
| 94 | 21 CFR 606.100(b)(15) | Schedules and procedures for equipment & calibration |