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

Source: https://www.globalkeysolutions.net/records/483/eisai-company-ltd/a5f97b7a-33a8-476b-bfdb-eeac694de11c

> 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 Biological Products Operations - Division I
- Summary: Eisai Company Ltd. in Kakamigahara, Gifu, Japan, was inspected by the FDA on November 1-2, 2022. The inspection revealed significant deficiencies in laboratory controls, specifically concerning the integrity and retention of electronic data and the lack of audit trail capabilities for testing systems. These issues indicate a failure to ensure the quality and purity of in-process materials and drug products.

## Related Documents

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- [483 - 2022-11-01](https://www.globalkeysolutions.net/records/483/eisai-company-ltd/c8868908-8632-455c-9d1b-f9098bd68460)
- [483 - 2023-10-27](https://www.globalkeysolutions.net/records/483/eisai-company-ltd/7ae42595-a466-4506-ba9a-3d4716ce1034)

## 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-biological-products-operations-division-i/49c53dac-7724-4c8c-8708-4f5779ea69c1