# FDA 483 - Eisai Company Ltd. - October 27, 2023

Source: https://www.globalkeysolutions.net/records/483/eisai-company-ltd/7fd8e7d9-096a-4649-a299-3e5a14dd1033

> FDA 483 for Eisai Company Ltd. on October 27, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Eisai Company Ltd.
- Inspection Date: 2023-10-27
- Product Type: drugs
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: Eisai Company Ltd. in Kakamigahara, Gifu, Japan, was inspected by the FDA from October 23-27, 2023. The inspection revealed significant issues with the firm's quality control unit, including a lack of oversight in batch record issuance and inadequate review of warehouse temperature data. Additionally, the firm failed to store drug product capsules under appropriate humidity conditions, potentially affecting their quality.

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## Related Officers

- [Bijoy Panicker](https://www.globalkeysolutions.net/people/bijoy-panicker/1c6ec57f-e02e-49b8-8b59-1853f3d2947a)
- [Ankur C. Patel](https://www.globalkeysolutions.net/people/ankur-c-patel/602c7d14-2c48-4929-a07b-6e4c235d7f13)

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

Office: https://www.globalkeysolutions.net/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd