776083
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 21, 2012
- Fiscal Year
- 2012
- Product Type
- Devices
- Project Area
- Bioresearch Monitoring
- Location
- Grosse Pointe Woods, MI (United States)
Additional Details
IRB
Citations
| ID | CFR | Description |
|---|---|---|
| 2916 | 21 CFR 812.7(d) | Investigational device represented as safe and /or effective |
| 7286 | 21 CFR 56.108(b)(1) | Prompt reporting of unanticipated problems |