FDA Inspection 616646 — Genetics & IVF Institute IRB
The FDA completed an inspection of Genetics & IVF Institute IRB on October 1, 2009 in Fairfax, VA. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 8 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- October 1, 2009
- Fiscal Year
- 2010
- Product Type
- Devices
- Project Area
- Bioresearch Monitoring
- Location
- Fairfax, VA (United States)
Additional Details
IRB
Citations
| ID | CFR | Description |
|---|---|---|
| 7278 | 21 CFR 56.107(e) | Conflict of interest |
| 7290 | 21 CFR 56.108(c) | Members present for review |
| 7318 | 21 CFR 56.115(a)(2) | Minutes of IRB meetings |
| 7319 | 21 CFR 56.115(a)(3) | Records of continuing review |
| 7321 | 21 CFR 56.110(c) | Method to keep members advised |
| 7322 | 21 CFR 56.111 (a)(2) | Risks to subjects reasonable |
| 7334 | 21 CFR 56.115(a)(5) | List of members |
| 7654 | 21 CFR 56.110(b) | Research not eligible for expedited review |