1232094
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 7, 2024
- Fiscal Year
- 2024
- Product Type
- Drugs
- Project Area
- Bioresearch Monitoring
- Location
- Winston Salem, NC (United States)
Additional Details
Radioactive Drug Research Committee
Citations
| ID | CFR | Description |
|---|---|---|
| 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 |
| 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 |
| 17965 | 21 CFR 361.1(c)(3) | Annual reports not submitted to FDA |
| 17968 | 21 CFR 361.1(c)(3) | FDA research proposals not reported +30 subjects |