FDA Inspection 895920 — Indiana Univ Medical Center RDRC
The FDA completed an inspection of Indiana Univ Medical Center RDRC on Sep 12, 2014 in Indianapolis, IN. 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
- Sep 12, 2014
- Fiscal Year
- 2014
- Product Type
- Drugs
- Project Area
- Bioresearch Monitoring
- Location
- Indianapolis, IN (United States)
Additional Details
Radioactive Drug Research Committee
Citations
| ID | CFR | Description |
|---|---|---|
| 17947 | 21 CFR 361.1(c)(1)(ii) | RDRC not incl trained person to formulate radioactive drugs |
| 17962 | 21 CFR 361.1(c)(2) | Numerical votes not in the minutes of any RDRC meetings |
| 17968 | 21 CFR 361.1(c)(3) | FDA research proposals not reported +30 subjects |