Eisai, Inc. – FDA 483, Apr 9, 2024

Eisai, Inc. in Baltimore, MD, was cited for significant deficiencies in its quality control and equipment management systems. The inspection revealed failures in calibrating critical manufacturing equipment, inadequate investigations into environmental monitoring excursions, and a lack of timely Out-Of-Specification (OOS) investigations. These issues indicate a moderate level of non-compliance with good manufacturing practices.