Ascent Pharmaceuticals IncSeptember 15, 2022

FDA 483 - Ascent Pharmaceuticals Inc - September 15, 2022

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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.

Company: Ascent Pharmaceuticals Inc
Inspection Date: September 15, 2022
Product Type: Drugs
Office: Division of Human and Animal Food Operations - East I
Person: Tyanna N. Hadley (investigator)

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ID · 2e23b981-2208-442a-b00c-5dea4a7b4772