FDA 483 - Eisai Company Ltd. - December 21, 2018

Eisai Company Ltd. in Kakamigahara, Gifu, Japan, was inspected by the FDA from December 17-21, 2018, revealing significant deficiencies across multiple areas. The inspection found issues with production phase time limits, cleaning validation, equipment maintenance, record availability, laboratory controls, and employee training. These observations indicate a lack of adherence to good manufacturing practices that could impact drug product quality and integrity.