FDA 483 - Eisai Company Ltd. - October 27, 2023

Eisai Company Ltd. in Kakamigahara, Gifu, Japan, was inspected by the FDA from October 23-27, 2023. The inspection revealed significant issues with the firm's quality control unit, including a lack of oversight in batch record issuance and inadequate review of warehouse temperature data. Additionally, the firm failed to store drug product capsules under appropriate humidity conditions, potentially affecting their quality.