Drug factory · FDA FEI 3002806886

Eisai Co., Ltd.

22, Sunayama, Kamisu-shi, Japan

Japan: 1

Problems found, fixed voluntarily at FDA's last inspection, Jul 24, 2026.

Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.

6 drug inspections on record since 2010: 2 with no problems, 4 with problems fixed voluntarily, 0 with FDA action.

What it does, for whom

DrugRoleForNDC
DonepezilMakes the active ingredient and tests it Eisai Inc. 62856-245, 62856-246, 62856-247 +2
EribulinMakes the active ingredient Eisai Inc. 62856-389
LemborexantMakes the active ingredient and tests it Eisai Inc. 62856-405, 62856-410, 62856-455
LenvatinibMakes the active ingredient Eisai Inc. 62856-704, 62856-708, 62856-710 +5
PerampanelMakes the active ingredient Eisai Inc. 62856-272, 62856-274, 62856-276 +4

FDA inspection history

EndedResultProgramProblems noted
Jul 24, 2026Problems found, fixed voluntarilyDrug Quality Assurance—
Nov 18, 2022Problems found, fixed voluntarilyDrug Quality Assurance—
Sep 15, 2017Problems found, fixed voluntarilyDrug Quality Assurance—
Nov 20, 2014Problems found, fixed voluntarilyDrug Quality Assurance—
Apr 20, 2012No problems foundDrug Quality Assurance—
Jun 10, 2010No problems foundDrug Quality Assurance—

Registered with FDA for: analysis; api manufacture.