483
Eisai Company Ltd.FDA 483 - Eisai Company Ltd. - June 28, 2019
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.
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ID · 74314d7e-eb90-4dca-9b43-ce25b021db49