601854
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- June 30, 2009
- Fiscal Year
- 2009
- Product Type
- Devices
- Project Area
- Bioresearch Monitoring
- Location
- Fairfax, VA (United States)
Additional Details
Sponsor, Contract Research Organization
Citations
| ID | CFR | Description |
|---|---|---|
| 2928 | 21 CFR 812.40 | Sponsors' general responsibilities |
| 2949 | 21 CFR 812.46(a) | Sponsor securing investigator compliance |
| 3002 | 21 CFR 812.140(b)(5) | Sponsor records of adverse device effects & complaints |