FDA Inspection 704908 — Albert Einstein College of Medicine IRB
The FDA completed an inspection of Albert Einstein College of Medicine IRB on January 20, 2011 in Bronx, NY. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- January 20, 2011
- Fiscal Year
- 2011
- Product Type
- Drugs
- Project Area
- Bioresearch Monitoring
- Location
- Bronx, NY (United States)
Additional Details
IRB
Citations
| ID | CFR | Description |
|---|---|---|
| 7318 | 21 CFR 56.115(a)(2) | Minutes of IRB meetings |
| 7321 | 21 CFR 56.110(c) | Method to keep members advised |
| 7334 | 21 CFR 56.115(a)(5) | List of members |