FDA 483 - Alvogen, Inc - June 10, 2021

Alvogen, Inc. in Morristown, NJ, underwent an inspection of its corporate office, revealing a significant deficiency in its Risk Evaluation and Mitigation Strategy (REMS) program. The firm failed to maintain a required REMS Program website link on its product website, which is a critical component of its approved REMS Implementation System. This indicates a lapse in adhering to established safety and communication protocols for opioid analgesic products.