Eisai Company Ltd.June 28, 2019

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

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Record Details

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.

Company: Eisai Company Ltd.
Inspection Date: June 28, 2019
Product Type: Drugs
Office: Office of Biological Products Operations - Division I
Person: Nayan J. Patel (Senior Lead Reviewer and Intercenter Consult Team Leader)

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ID · 74314d7e-eb90-4dca-9b43-ce25b021db49