1019036
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- July 7, 2017
- Fiscal Year
- 2017
- Product Type
- Devices
- Project Area
- Bioresearch Monitoring
- Location
- Fremont, CA (United States)
Additional Details
Sponsor, Contract Research Organization
Citations
| ID | CFR | Description |
|---|---|---|
| 14523 | 21 CFR 812.43(c) | No investigator agreement |
| 2928 | 21 CFR 812.40 | Sponsors' general responsibilities |
| 2933 | 21 CFR 812.43(a) | Investigator(s) not qualified |