988869
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- May 25, 2016
- Fiscal Year
- 2016
- Product Type
- Devices
- Project Area
- Bioresearch Monitoring
- Location
- Moffett Field, CA (United States)
Additional Details
Clinical Investigator (CI)
Citations
| ID | CFR | Description |
|---|---|---|
| 2969 | 21 CFR 812.100 | No investigator protection - subject rights, safety, welfare |
| 3064 | 21 CFR 812.140(a)(4) | Investigator protocol records inadequate |