FDA Inspection 833682 — Indiana Orthopaedic Hospital, LLC IRB #1
The FDA completed an inspection of Indiana Orthopaedic Hospital, LLC IRB #1 on May 24, 2013 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). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- May 24, 2013
- Fiscal Year
- 2013
- Product Type
- Devices
- Project Area
- Bioresearch Monitoring
- Location
- Indianapolis, IN (United States)
Additional Details
IRB
Citations
| ID | CFR | Description |
|---|---|---|
| 7281 | 21 CFR 56.108(a)(1) | Initial and continuing reviews |
| 7293 | 21 CFR 56.109(f) | Continuing review |
| 7334 | 21 CFR 56.115(a)(5) | List of members |