FDA Inspection 1242242 — NYU Robert Grossman School Of Medicine Radioactive Drug Research Committee
The FDA completed an inspection of NYU Robert Grossman School Of Medicine Radioactive Drug Research Committee on Jun 26, 2024 in New York, 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). 4 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jun 26, 2024
- Fiscal Year
- 2024
- Product Type
- Drugs
- Project Area
- Bioresearch Monitoring
- Location
- New York, NY (United States)
Additional Details
Radioactive Drug Research Committee
Citations
| ID | CFR | Description |
|---|---|---|
| 17958 | 21 CFR 361.1(c)(2) | Signatures of RDRC Chairman |
| 17961 | 21 CFR 361.1(c)(2) | RDRC has not kept minutes of its meetings |
| 17978 | 21 CFR 361.1(d)(5) | Obtaining informed consent |
| 17991 | 21 CFR 361.1(d)(9) | Institutional Review Board (IRB) approved research |