FDA Inspection 918097 — Kalispell Regional Medical Center, Inc. IRB #4
The FDA completed an inspection of Kalispell Regional Medical Center, Inc. IRB #4 on March 5, 2015 in Kalispell, MT. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 10 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- March 5, 2015
- Fiscal Year
- 2015
- Product Type
- Devices
- Project Area
- Bioresearch Monitoring
- Location
- Kalispell, MT (United States)
Additional Details
IRB
Citations
| ID | CFR | Description |
|---|---|---|
| 7286 | 21 CFR 56.108(b)(1) | Prompt reporting of unanticipated problems |
| 7293 | 21 CFR 56.109(f) | Continuing review |
| 7304 | 21 CFR 56.110(b)(1) | No more than minimal risk |
| 7318 | 21 CFR 56.115(a)(2) | Minutes of IRB meetings |
| 7334 | 21 CFR 56.115(a)(5) | List of members |
| 7342 | 21 CFR 56.108(b)(2) | Prompt reporting of noncompliance |
| 7371 | 21 CFR 56.108(a)(1) | Reporting findings and actions to investigator/institution |
| 7392 | 21 CFR 50.25(a)(7) | Whom to contact |
| 7654 | 21 CFR 56.110(b) | Research not eligible for expedited review |
| 7692 | 21 CFR 56.106(e) | Changes in contact or chairperson information |