# FDA 483 - Eisai Company Ltd. - December 21, 2018

Source: https://www.globalkeysolutions.net/records/483/eisai-company-ltd/3bee4a56-0e26-4371-977d-a900343008f7

> FDA 483 for Eisai Company Ltd. on December 21, 2018. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Eisai Company Ltd.
- Inspection Date: 2018-12-21
- 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 from December 17-21, 2018, revealing significant deficiencies across multiple areas. The inspection found issues with production phase time limits, cleaning validation, equipment maintenance, record availability, laboratory controls, and employee training. These observations indicate a lack of adherence to good manufacturing practices that could impact drug product quality and integrity.

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## Related Officers

- [Investigator](https://www.globalkeysolutions.net/people/saied-a-asbagh/215bfa90-995f-4310-baf3-cd9d37639b7b)

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