FDA Inspection 1079147 — Indiana Orthopaedic Hospital, LLC IRB #1
The FDA completed an inspection of Indiana Orthopaedic Hospital, LLC IRB #1 on Feb 13, 2019 in Indianapolis, IN. 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). 4 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Feb 13, 2019
- Fiscal Year
- 2019
- Product Type
- Devices
- Project Area
- Bioresearch Monitoring
- Location
- Indianapolis, IN (United States)
Additional Details
IRB
Citations
| ID | CFR | Description |
|---|---|---|
| 7276 | 21 CFR 56.107(c) | One scientific and one non-scientific member |
| 7293 | 21 CFR 56.109(f) | Continuing review |
| 7321 | 21 CFR 56.110(c) | Method to keep members advised |
| 7343 | 21 CFR 56.108(b)(3) | Reporting of suspension/termination |