FDA 483 - Eisai, Inc. - February 16, 2018

Eisai, Inc. in Woodcliff Lake, NJ, was cited for significant deficiencies in clinical trial data management and access control during an FDA inspection. The firm failed to adhere to its investigational plan, protocols, and internal procedures, leading to unauthorized access to unblinded study data and improper user access management for clinical databases. These issues indicate a serious breakdown in data integrity and protocol compliance for multiple studies.