483
Eisai Company Ltd.FDA 483 - Eisai Company Ltd. - June 05, 2026
Discuss this record with AI
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.
Record Details
An FDA inspection of Eisai Company Ltd.'s drug manufacturing facility in Kakamigahara, Gifu, Japan, revealed a significant observation regarding facility maintenance. Inspectors found unsanitary conditions, specifically dust and debris, in a machine room located directly above manufacturing spaces. This indicates a failure to maintain buildings in a clean and sanitary state, despite the firm having an SOP for cleaning the area.
- Office
- Office of Partnerships
- Person
Open in Dashboard
ID · 5da76e40-5567-4aea-8d42-298b412ff04d