810454
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- November 27, 2012
- Fiscal Year
- 2013
- Product Type
- Devices
- Project Area
- Bioresearch Monitoring
- Location
- Santa Rosa, CA (United States)
Additional Details
Sponsor, Contract Research Organization
Citations
| ID | CFR | Description |
|---|---|---|
| 14523 | 21 CFR 812.43(c) | No investigator agreement |
| 2994 | 21 CFR 812.140(b)(3) | Sponsor records of investigator agreements inadequate |