FDA Inspection 659896 — Rush University System For Health IRB
The FDA completed an inspection of Rush University System For Health IRB on Apr 2, 2010 in Chicago, IL. 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: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Apr 2, 2010
- Fiscal Year
- 2010
- Product Type
- Drugs
- Project Area
- Bioresearch Monitoring
- Location
- Chicago, IL (United States)
Additional Details
IRB
Citations
| ID | CFR | Description |
|---|---|---|
| 7321 | 21 CFR 56.110(c) | Method to keep members advised |
| 7335 | 21 CFR 56.115(a)(6) | Written procedures per 56.108(a) and (b) |
| 7369 | 21 CFR 56.109(h) | Children as subjects |