FDA 483 - Avadel CNS Pharmaceuticals LLC - September 12, 2025

Avadel CNS Pharmaceuticals LLC, located in Chesterfield, MO, was inspected regarding its Risk Evaluation and Mitigation Strategy (REMS) program. The inspection revealed that the firm failed to comply with its approved REMS audit plan and schedule. Specifically, several certified pharmacies were audited outside the required 90-day initial timeframe or the annual audit timeframe for the drug Lumryz.