Atlas

FDA-Inspected Site

Eisai Manufacturing Ltd

5 FDA inspections are on record for Eisai Manufacturing Ltd in Hatfield, United Kingdom.

Clean· No action indicated

Hatfield, United Kingdom · Last updated July 10, 2026

Overview

  • 5 FDA inspections are on record.
  • 4 inspections produced a Form 483.
  • The most recent recorded inspection date is 2022-01-21.

At a glance

Inspections

5

Form 483s

4

EIRs

0

Last outcome

Clean

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
19 Jan 2022 – 21 Jan 2022Human DrugsClean
28 Jan 2019 – 1 Feb 2019Human Drugs483View 483 →
9 May 2016 – 13 May 2016Human Drugs483View 483 →
8 Jul 2013 – 12 Jul 2013Human Drugs483View 483 →
23 Jul 2010Not recorded483On file

Observations on record

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

1 Feb 2019
21 CFR 312.50

General responsibilities of sponsors

Cited by Craig A Garmendia, Jean M Mulinde

13 May 2016
21 CFR 211.192

Investigations of discrepancies, failures

Cited by Liming Zhang

13 May 2016
21 CFR 211.63

Equipment Design, Size and Location

Cited by Liming Zhang

12 Jul 2013
21 CFR 211.67(b)

Written procedures fail to include

Cited by Walden H Lee, Daniel J Roberts

12 Jul 2013
21 CFR 211.84(d)(2)

Reports of Analysis (Components)

Cited by Walden H Lee, Daniel J Roberts

Investigators

FDA investigators tied to this site in the record.

MRA McCulloughJ1 insp.
Craig A Garmendia1 insp.
Jean M Mulinde1 insp.
Liming Zhang1 insp.
Walden H Lee1 insp.
Daniel J Roberts1 insp.
Barbara D Wright1 insp.

Recurring citations

CFR citation patterns observed across this site's inspections.

CitationWhat it coversCited
21 CFR 211.192Cited across public-safe Form 483 observations1x
21 CFR 211.63Cited across public-safe Form 483 observations1x
21 CFR 211.67(b)Cited across public-safe Form 483 observations1x
21 CFR 211.84(d)(2)Cited across public-safe Form 483 observations1x
21 CFR 312.50Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind Eisai Manufacturing Ltd's 4 Form 483s

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