701261
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- December 8, 2010
- Fiscal Year
- 2011
- Product Type
- Devices
- Project Area
- Bioresearch Monitoring
- Location
- Bloomington, IN (United States)
Additional Details
Sponsor, Contract Research Organization
Citations
| ID | CFR | Description |
|---|---|---|
| 2968 | 21 CFR 812.100 | Investigator non-compliance with agreement/plan/regulations |
| 2970 | 21 CFR 812.100 | Investigator lack of informed consent |