FDA 483 - Jazz Pharmaceuticals, Inc - June 10, 2019

Jazz Pharmaceuticals, Inc. in Palo Alto, CA, was cited for significant issues related to pharmacovigilance and risk management during an FDA inspection. The firm failed to timely report 126 serious and unexpected adverse drug experiences for its product Defitelio and did not maintain required records for 10 years. Additionally, the company did not adequately address non-compliant pharmacies within its Xyrem REMS program.