# FDA 483 - Eisai Company Ltd. - June 28, 2019

Source: https://www.globalkeysolutions.net/records/483/eisai-company-ltd/74314d7e-eb90-4dca-9b43-ce25b021db49

> FDA 483 for Eisai Company Ltd. on June 28, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Eisai Company Ltd.
- Inspection Date: 2019-06-28
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Eisai Company Ltd., a bulk finished drug manufacturer in Kakamigahara, Japan, revealed deficiencies in production and process controls and equipment maintenance. The firm failed to document developmental studies for tablet dissolution parameters and lacked proper records for cleaning and maintenance activities, including observed material accumulation and undocumented air vent devices.

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## Related Officers

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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