Eisai Company Ltd. – FDA 483, Nov 1, 2022

An FDA inspection of Eisai Company Ltd., a bulk finished drug manufacturer and contract testing laboratory in Kakamigahara, Japan, revealed significant deficiencies in laboratory controls. Specifically, the firm failed to ensure data integrity for electronic laboratory data, including issues with unauthorized changes, lack of audit trails, and overwriting of raw electronic data. These findings indicate a serious lapse in quality control and data management practices.