FDA Inspection 905730 — Institutional Review Board of Franciscan Health Lafayette
The FDA completed an inspection of Institutional Review Board of Franciscan Health Lafayette on December 3, 2014 in Lafayette, IN. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 3 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- December 3, 2014
- Fiscal Year
- 2015
- Product Type
- Drugs
- Project Area
- Bioresearch Monitoring
- Location
- Lafayette, 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 |