964811
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- February 19, 2016
- Fiscal Year
- 2016
- Product Type
- Devices
- Project Area
- Bioresearch Monitoring
- Location
- Branchburg, NJ (United States)
Additional Details
Sponsor, Contract Research Organization
Citations
| ID | CFR | Description |
|---|---|---|
| 7270 | 21 CFR 56.103(a) | IRB review requirement |
| 9674 | 21 CFR 809.10(c)(2)(ii) | Not exempt--lacks For Investigational Use statement |