FDA 483 - Braeburn Pharmaceuticals Inc. - February 08, 2018

An FDA inspection of Braeburn Pharmaceuticals Inc.'s corporate office in Princeton, NJ, revealed two significant issues. The firm failed to report serious and unexpected adverse drug experiences within the required 15-day timeframe. Additionally, Braeburn Pharmaceuticals did not adhere to the audit plan and schedule outlined in its approved REMS Implementation System for Probuphine inserters.