666800
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- May 21, 2010
- Fiscal Year
- 2010
- Product Type
- Devices
- Project Area
- Bioresearch Monitoring
- Location
- Dallas, TX (United States)
Additional Details
Sponsor, Contract Research Organization
Citations
| ID | CFR | Description |
|---|---|---|
| 14518 | 21 CFR 812.35(a)(3)(iv) | No 5 day notification of IDE change |
| 2928 | 21 CFR 812.40 | Sponsors' general responsibilities |