1025976
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- September 21, 2017
- Fiscal Year
- 2017
- Product Type
- Drugs
- Project Area
- Bioresearch Monitoring
- Location
- Berkeley, CA (United States)
Additional Details
Radioactive Drug Research Committee
Citations
| ID | CFR | Description |
|---|---|---|
| 17958 | 21 CFR 361.1(c)(2) | Signatures of RDRC Chairman |
| 17962 | 21 CFR 361.1(c)(2) | Numerical votes not in the minutes of any RDRC meetings |
| 17964 | 21 CFR 361.1(c)(2) | RDRC did not meet at least once each quarter |
| 17968 | 21 CFR 361.1(c)(3) | FDA research proposals not reported +30 subjects |
| 17993 | 21 CFR 361.1(f)(1) | Packaging, labeling - Rx only |
| 17997 | 21 CFR 361.1(f)(5) | Label - radioactivity, amount |