483
Eisai Company Ltd.FDA 483 - Eisai Company Ltd. - December 21, 2018
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Record Details
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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