FDA Inspection 722706 — Maimonides Medical Center IRB
The FDA completed an inspection of Maimonides Medical Center IRB on May 5, 2011 in Brooklyn, NY. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 3 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- May 5, 2011
- Fiscal Year
- 2011
- Product Type
- Biologics
- Project Area
- Bioresearch Monitoring
- Location
- Brooklyn, NY (United States)
Additional Details
IRB
Citations
| ID | CFR | Description |
|---|---|---|
| 7278 | 21 CFR 56.107(e) | Conflict of interest |
| 7318 | 21 CFR 56.115(a)(2) | Minutes of IRB meetings |
| 7335 | 21 CFR 56.115(a)(6) | Written procedures per 56.108(a) and (b) |