FDA Inspection 856798 — Amita Health IRB
The FDA completed an inspection of Amita Health IRB on Dec 12, 2013 in Elk Grove Village, IL. The inspection was classified OAI (Official Action Indicated — regulatory and/or administrative actions are recommended). 3 citations were issued during this inspection. Product area: Devices.
Inspection details
- Classification
- Official Action Indicated (OAI)
- End Date
- Dec 12, 2013
- Fiscal Year
- 2014
- Product Type
- Devices
- Project Area
- Bioresearch Monitoring
- Location
- Elk Grove Village, IL (United States)
Additional details
IRB
Citations
| ID | CFR | Description |
|---|---|---|
| 7297 | 21 CFR 56.109(b) | Information given to subjects |
| 7305 | 21 CFR 56.110(b)(2) | Minor changes |
| 7321 | 21 CFR 56.110(c) | Method to keep members advised |