FDA Inspection 1084382 — Kalispell Regional Medical Center, Inc. IRB #4
The FDA completed an inspection of Kalispell Regional Medical Center, Inc. IRB #4 on March 29, 2019 in Kalispell, MT. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 1 citation was issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 29, 2019
- Fiscal Year
- 2019
- Product Type
- Biologics
- Project Area
- Bioresearch Monitoring
- Location
- Kalispell, MT (United States)
Additional Details
IRB
Citations
| ID | CFR | Description |
|---|---|---|
| 7654 | 21 CFR 56.110(b) | Research not eligible for expedited review |