FDA 483 - Jazz Pharmaceuticals, Inc - January 27, 2016

An FDA inspection of Jazz Pharmaceuticals, Inc. in Palo Alto, CA, identified a significant issue related to the monitoring of clinical trials. The firm failed to ensure that an investigation was conducted in accordance with the investigational plan, specifically regarding the oversight of IRB approvals. This resulted in multiple clinical sites having lapsed IRB approvals, with one site having an actively enrolled subject during a period of lapsed approval, indicating a serious lapse in clinical trial oversight.