FDA 483 - Allergan, PLC. - April 11, 2019

An FDA inspection of Allergan, PLC.'s corporate headquarters in Madison, NJ, revealed significant deficiencies in their Risk Evaluation and Mitigation Strategy (REMS) program for opioid analgesics. The firm failed to properly dispense the required Medication Guide and did not adequately maintain its REMS program website and support systems. These issues indicate a failure to ensure critical safety information is accessible to patients and healthcare providers.