FDA Inspection 1232094 — Wake Forest University Health Sciences RDRC
The FDA completed an inspection of Wake Forest University Health Sciences RDRC on Mar 7, 2024 in Winston Salem, NC. 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). 6 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Mar 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 |