Atlas

FDA-Inspected Site

Eisai Company Ltd.

6 FDA inspections are on record for Eisai Company Ltd. in Kakamigahara, Japan.

483· Form 483 issued

Kakamigahara, Japan · Last updated August 15, 2026

Overview

  • 6 FDA inspections are on record.
  • 5 inspections produced a Form 483.
  • The most recent recorded inspection date is 2026-06-05.

At a glance

Inspections

6

Form 483s

5

EIRs

0

Last outcome

Form 483

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
1 Jun 2026 – 5 Jun 2026Human Drugs483On file
23 Oct 2023 – 27 Oct 2023Human Drugs483View 483 →
1 Nov 2022 – 2 Nov 2022Human Drugs483On file
24 Jun 2019 – 28 Jun 2019Human Drugs483On file
17 Dec 2018 – 21 Dec 2018Human Drugs483View 483 →
15 Feb 2016 – 19 Feb 2016Human DrugsClean

Observations on record

Form 483 observations cited at this site, most recent first.

27 Oct 2023
21 CFR 211.142(b)

Storage under appropriate conditions

Cited by Bijoy Panicker, Ankur C Patel

27 Oct 2023
21 CFR 211.22(d)

Procedures not in writing, fully followed

Cited by Bijoy Panicker, Ankur C Patel

21 Dec 2018
21 CFR 211.160(a)

Following/documenting laboratory controls

Cited by Saied A Asbagh

21 Dec 2018
21 CFR 211.180(c)

Records not made readily available to FDA

Cited by Saied A Asbagh

21 Dec 2018
21 CFR 211.67(a)

Cleaning / Sanitizing / Maintenance

Cited by Saied A Asbagh

Investigators

FDA investigators tied to this site in the record.

Wayne D Mcgrath1 insp.
Bijoy Panicker1 insp.
Ankur C Patel1 insp.
Rumany C Penn1 insp.
Nayan J Patel1 insp.
Saied A Asbagh1 insp.
Samina S Khan1 insp.

Recurring citations

CFR citation patterns observed across this site's inspections.

CitationWhat it coversCited
21 CFR 211.111Cited across public-safe Form 483 observations1x
21 CFR 211.142(b)Cited across public-safe Form 483 observations1x
21 CFR 211.160(a)Cited across public-safe Form 483 observations1x
21 CFR 211.180(c)Cited across public-safe Form 483 observations1x
21 CFR 211.22(d)Cited across public-safe Form 483 observations1x
21 CFR 211.25(a)Cited across public-safe Form 483 observations1x
21 CFR 211.67(a)Cited across public-safe Form 483 observations1x
21 CFR 211.67(b)Cited across public-safe Form 483 observations1x
21 CFR 211.68(a)Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind Eisai Company Ltd.'s 5 Form 483s

Source PDFs, verbatim observations, and recurring CFR citations, so your team knows what this site gets cited for.

  • The site's full inspection history, with every Form 483 and its outcome
  • Warning letters and recalls tied to the company behind it
  • Whether recurring CFR citations get closed out or repeat