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483
•Eisai Company Ltd.•June 28, 2019

Eisai Company Ltd. – FDA 483, Jun 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.

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)
View Company Profile

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

Other documents for Eisai Company Ltd.
  • 483 - 2026-06-05June 5, 2026
  • 483 - 2023-10-27October 27, 2023
  • 483 - 2022-11-01November 1, 2022
  • 483 - 2018-12-21December 21, 2018

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