# FDA 483 - Eisai Company Ltd. - June 05, 2026

Source: https://www.keypedia.com/records/483/eisai-company-ltd/5da76e40-5567-4aea-8d42-298b412ff04d

> FDA 483 for Eisai Company Ltd. on June 05, 2026. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Eisai Company Ltd.
- Inspection Date: 2026-06-05
- Product Type: drugs
- Office Name: Office of Partnerships
- Summary: An FDA inspection of Eisai Company Ltd.'s drug manufacturing facility in Kakamigahara, Gifu, Japan, revealed a significant observation regarding facility maintenance. Inspectors found unsanitary conditions, specifically dust and debris, in a machine room located directly above manufacturing spaces. This indicates a failure to maintain buildings in a clean and sanitary state, despite the firm having an SOP for cleaning the area.

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## Related Officers

- [Wayne D. Mcgrath](https://www.keypedia.com/people/wayne-d-mcgrath/42db5ab0-2e0b-4909-951c-e7621cd04f6e)

Company: https://www.keypedia.com/companies/eisai-company-ltd/3b8d9042-088d-4b84-9382-fcdcfd5ef360

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