FDA Inspection 1281792 — Avadel CNS Pharmaceuticals LLC
The FDA completed an inspection of Avadel CNS Pharmaceuticals LLC on September 12, 2025 in Chesterfield, MO. 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
- September 12, 2025
- Fiscal Year
- 2025
- Product Type
- Drugs
- Project Area
- Bioresearch Monitoring
- Location
- Chesterfield, MO (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 |