FDA Inspection 1062959 — Stony Brook University RDRC #160
The FDA completed an inspection of Stony Brook University RDRC #160 on Aug 9, 2018 in Stony Brook, NY. 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). 5 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Aug 9, 2018
- Fiscal Year
- 2018
- Product Type
- Drugs
- Project Area
- Bioresearch Monitoring
- Location
- Stony Brook, NY (United States)
Additional Details
Radioactive Drug Research Committee
Citations
| ID | CFR | Description |
|---|---|---|
| 17961 | 21 CFR 361.1(c)(2) | RDRC has not kept minutes of its meetings |
| 17993 | 21 CFR 361.1(f)(1) | Packaging, labeling - Rx only |
| 17994 | 21 CFR 361.1(f)(2) | Label - For research use |
| 18001 | 21 CFR 361.1(f)(9) | Label - Name, address manufacturer |
| 18003 | 21 CFR 361.1(f)(11) | Label - Parenteral drug, sterile |