FDA Inspection 1144326 — Alvogen, Inc
The FDA completed an inspection of Alvogen, Inc on June 10, 2021 in Morristown, NJ. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 1 citation was issued during this inspection. Product area: Drugs.
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 |