FDA Inspection 1063537 — Eastern Idaho Regional Medical Center IRB, HCA
The FDA completed an inspection of Eastern Idaho Regional Medical Center IRB, HCA on Aug 24, 2018 in Idaho Falls, ID. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 5 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Aug 24, 2018
- Fiscal Year
- 2018
- Product Type
- Drugs
- Project Area
- Bioresearch Monitoring
- Location
- Idaho Falls, ID (United States)
Additional Details
IRB
Citations
| ID | CFR | Description |
|---|---|---|
| 7281 | 21 CFR 56.108(a)(1) | Initial and continuing reviews |
| 7290 | 21 CFR 56.108(c) | Members present for review |
| 7317 | 21 CFR 56.115(a)(1) | Copies of all research proposals and related documents |
| 7334 | 21 CFR 56.115(a)(5) | List of members |
| 7371 | 21 CFR 56.108(a)(1) | Reporting findings and actions to investigator/institution |