FDA 483 - Ascent Pharmaceuticals Inc - September 15, 2022

An FDA inspection of Ascent Pharmaceuticals Inc's corporate headquarters in Central Islip, NY, revealed a significant lapse in their Risk Evaluation and Mitigation Strategy (REMS) program. The firm failed to maintain its approved REMS Implementation System by not providing required REMS-specific links on its product website to the official REMS Program website. This indicates a failure to comply with post-market requirements for their opioid analgesic products.