FDA Inspection 1267751 — Stanford University School Of Medicine Radioactive Drug Research Committee
The FDA completed an inspection of Stanford University School Of Medicine Radioactive Drug Research Committee on Apr 21, 2025 in Stanford, CA. 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
- Apr 21, 2025
- Fiscal Year
- 2025
- Product Type
- Drugs
- Project Area
- Bioresearch Monitoring
- Location
- Stanford, CA (United States)
Additional Details
Radioactive Drug Research Committee
Citations
| ID | CFR | Description |
|---|---|---|
| 17978 | 21 CFR 361.1(d)(5) | Obtaining informed consent |
| 17983 | 21 CFR 361.1(d)(6) | Radioactive drug - chemical standard |
| 17984 | 21 CFR 361.1(d)(6) | Radioactive materials for parenteral use - preparation |
| 17993 | 21 CFR 361.1(f)(1) | Packaging, labeling - Rx only |