1059075
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- July 17, 2018
- Fiscal Year
- 2018
- Product Type
- Drugs
- Project Area
- Bioresearch Monitoring
- Location
- Winston Salem, NC (United States)
Additional Details
Radioactive Drug Research Committee
Citations
| ID | CFR | Description |
|---|---|---|
| 17958 | 21 CFR 361.1(c)(2) | Signatures of RDRC Chairman |
| 17959 | 21 CFR 361.1(c)(2) | >50% of members not at RDRC meeting |
| 17960 | 21 CFR 361.1(c)(2) | Representation of the required fields of expertise |
| 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 |
| 17997 | 21 CFR 361.1(f)(5) | Label - radioactivity, amount |
| 18001 | 21 CFR 361.1(f)(9) | Label - Name, address manufacturer |
| 18003 | 21 CFR 361.1(f)(11) | Label - Parenteral drug, sterile |