1016008
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- June 15, 2017
- Fiscal Year
- 2017
- 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 |
| 17960 | 21 CFR 361.1(c)(2) | Representation of the required fields of expertise |
| 17961 | 21 CFR 361.1(c)(2) | RDRC has not kept minutes of its meetings |
| 17962 | 21 CFR 361.1(c)(2) | Numerical votes not in the minutes of any RDRC meetings |
| 17993 | 21 CFR 361.1(f)(1) | Packaging, labeling - Rx only |
| 17994 | 21 CFR 361.1(f)(2) | Label - For research use |
| 17996 | 21 CFR 361.1(f)(4) | Label - Established name, quantity active ingredient |
| 18001 | 21 CFR 361.1(f)(9) | Label - Name, address manufacturer |
| 18003 | 21 CFR 361.1(f)(11) | Label - Parenteral drug, sterile |