FDA Inspection 1017405 — St. Charles Medical Center
The FDA completed an inspection of St. Charles Medical Center on April 12, 2017 in Bend, 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: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- April 12, 2017
- Fiscal Year
- 2017
- Product Type
- Devices
- Project Area
- Bioresearch Monitoring
- Location
- Bend, OR (United States)
Additional Details
IRB
Citations
| ID | CFR | Description |
|---|---|---|
| 7305 | 21 CFR 56.110(b)(2) | Minor changes |
| 7318 | 21 CFR 56.115(a)(2) | Minutes of IRB meetings |
| 7319 | 21 CFR 56.115(a)(3) | Records of continuing review |
| 7695 | 21 CFR 50.25(c) | ClincialTrials.gov statement |