FDA Inspection 585769 — Indiana Orthopaedic Hospital, LLC IRB #1
The FDA completed an inspection of Indiana Orthopaedic Hospital, LLC IRB #1 on May 27, 2009 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). 6 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- May 27, 2009
- Fiscal Year
- 2009
- 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 |
| 7290 | 21 CFR 56.108(c) | Members present for review |
| 7318 | 21 CFR 56.115(a)(2) | Minutes of IRB meetings |
| 7334 | 21 CFR 56.115(a)(5) | List of members |
| 7391 | 21 CFR 50.25(a)(5) | Confidentiality, FDA inspection of records |
| 7654 | 21 CFR 56.110(b) | Research not eligible for expedited review |