FDA Inspection 1102461 — Brigham and Women's Hospital RDRC
The FDA completed an inspection of Brigham and Women's Hospital RDRC on September 19, 2019 in Boston, MA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 6 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- September 19, 2019
- Fiscal Year
- 2019
- Product Type
- Drugs
- Project Area
- Bioresearch Monitoring
- Location
- Boston, MA (United States)
Additional Details
Radioactive Drug Research Committee
Citations
| ID | CFR | Description |
|---|---|---|
| 17958 | 21 CFR 361.1(c)(2) | Signatures of RDRC Chairman |
| 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 |
| 18003 | 21 CFR 361.1(f)(11) | Label - Parenteral drug, sterile |
| 18004 | 21 CFR 361.1(f)(12) | Label - Inactive ingredient, name |