# FDA 483 - Eisai Company Ltd. - November 01, 2022

Source: https://www.globalkeysolutions.net/records/483/eisai-company-ltd/c8868908-8632-455c-9d1b-f9098bd68460

> FDA 483 for Eisai Company Ltd. on November 01, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Eisai Company Ltd.
- Inspection Date: 2022-11-01
- Product Type: drugs
- Office Name: Office of Partnerships
- Summary: An FDA inspection of Eisai Company Ltd., a bulk finished drug manufacturer and contract testing laboratory in Kakamigahara, Japan, revealed significant deficiencies in laboratory controls. Specifically, the firm failed to ensure data integrity for electronic laboratory data, including issues with unauthorized changes, lack of audit trails, and overwriting of raw electronic data. These findings indicate a serious lapse in quality control and data management practices.

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## Related Officers

- [Compliance Officer](https://www.globalkeysolutions.net/people/rumany-c-penn/021eb1e0-8de0-403f-9596-3e76624b2e5a)

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

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