FDA 483 - Eisai Co., Ltd. Kashima Plant - November 14, 2022

This FDA Form 483 was issued to Eisai Co., Ltd. Kashima Plant in Ibaraki, Japan, following an inspection of their Active Pharmaceutical Ingredient manufacturing facility. Observations primarily concerned significant data integrity issues with computer systems, inadequate yield calculations, uncontrolled labeling operations, and improper storage conditions for materials. These findings indicate a lack of robust controls across critical manufacturing and quality processes.