FDA 483 - Eisai Company Ltd. - November 01, 2022

Eisai Company Ltd. in Kakamigahara, Gifu, Japan, was inspected by the FDA on November 1-2, 2022. The inspection revealed significant deficiencies in laboratory controls, specifically concerning the integrity and retention of electronic data and the lack of audit trail capabilities for testing systems. These issues indicate a failure to ensure the quality and purity of in-process materials and drug products.