1144326
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- June 10, 2021
- Fiscal Year
- 2021
- Product Type
- Drugs
- Project Area
- Bioresearch Monitoring
- Location
- Morristown, NJ (United States)
Additional Details
Risk Evaluation and Mitigation Strategies (REMS)
Citations
| ID | CFR | Description |
|---|---|---|
| 21360 | FDCA 505-1(f)(4) | Failure to comply with REMS Implementation System |