FDA Inspection 1059075 — Wake Forest University Health Sciences RDRC
The FDA completed an inspection of Wake Forest University Health Sciences RDRC on Jul 17, 2018 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). 9 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jul 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 |