854178
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- November 1, 2013
- Fiscal Year
- 2014
- Product Type
- Devices
- Project Area
- Bioresearch Monitoring
- Location
- Rancho Mirage, CA (United States)
Additional Details
Clinical Investigator (CI)
Citations
| ID | CFR | Description |
|---|---|---|
| 14505 | 21 CFR 812.140(a)(3) | Investigator's subject records inadequate |
| 2984 | 21 CFR 812.140(a)(3)(i) | Investigator records of informed consent inadequate |
| 7013 | 21 CFR 812.110(d) | Inadequate financial disclosure by investigator |