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