483
Eisai Co., Ltd. Kashima PlantEisai Co., Ltd. Kashima Plant – FDA 483, Jul 24, 2026
Record Details
An FDA inspection of Eisai Co. Ltd. Kashima Plant, an active pharmaceutical ingredient manufacturer, revealed two significant deficiencies. The firm failed to adequately calibrate analytical balances for their full range of use and lacked sufficient controls over computerized systems, allowing QA personnel administrator privileges that could lead to unauthorized data changes or omissions. These issues raise concerns about data integrity and product quality.
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ID · 1b463a04-f972-44d3-9e41-3f20062dd9e1
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