# Eisai Co., Ltd. Kashima Plant – FDA 483, Jul 24, 2026

Source: https://www.keypedia.com/records/483/eisai-co-ltd-kashima-plant/1b463a04-f972-44d3-9e41-3f20062dd9e1

> FDA 483 for Eisai Co., Ltd. Kashima Plant on July 24, 2026. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Eisai Co., Ltd. Kashima Plant
- Inspection Date: 2026-07-24
- Product Type: drugs
- Office Name: Office of Partnerships
- Summary: 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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Company: https://www.keypedia.com/companies/eisai-co-ltd-kashima-plant/70a3ccaf-c591-4ebf-952a-a2ee6a62e53c

Office: https://www.keypedia.com/offices/office-of-partnerships/83acc701-fc5a-4876-bb34-7499e31541d3