Eisai Co., Ltd. — FDA Facility Profile

FEI 3002806886

Eisai Co., Ltd. is an FDA-registered facility (FEI 3002806886) located in Ibaraki 314-0255, JP. Registered operations: ANALYSIS; API MANUFACTURE. RegDataLab tracks 6 FDA inspections at this facility.

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What FDA found at this site

Latest inspection
Jul 24, 2026: Voluntary Action Indicated (VAI)
Inspections on record
6 (4 VAI, 2 NAI)
Last OAI inspection
None on record
Warning letters
None matched to this FEI. Many letters do not state an FEI: search warning letters by company name
Import refusals
2

A Form 483 lists an inspector's observations. OAI means FDA recommends regulatory and/or administrative action. A warning letter is FDA's formal enforcement notice. No record here does not establish that a site is safe. Check this site on FDA's Data Dashboard.

Inspections and what FDA cited

Newest first. Citations are the inspector observations FDA publishes for the inspection.

DateResultWhat FDA cited
Jul 24, 2026Voluntary Action Indicated (VAI)No citations listed
Nov 18, 2022Voluntary Action Indicated (VAI)No citations listed
Sep 15, 2017Voluntary Action Indicated (VAI)No citations listed
Nov 20, 2014Voluntary Action Indicated (VAI)No citations listed
Apr 20, 2012No Action Indicated (NAI)No citations listed
Jun 10, 2010No Action Indicated (NAI)No citations listed

Facility details

Company
Eisai Co., Ltd.
Location
Ibaraki 314-0255 (JP)
Registration Expires
Dec 31, 2026
Operations
ANALYSIS; API MANUFACTURE
Source
decrs

Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.