Atlas

FDA-Inspected Site

Takeda Ireland Limited

6 FDA inspections are on record for Takeda Ireland Limited in Kilruddery, Ireland.

Clean· No action indicated

Kilruddery, Ireland · Last updated July 10, 2026

Overview

  • 6 FDA inspections are on record.
  • 2 inspections produced a Form 483.
  • The most recent recorded inspection date is 2020-02-28.

At a glance

Inspections

6

Form 483s

2

EIRs

0

Last outcome

Clean

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
24 Feb 2020 – 28 Feb 2020Human DrugsClean
23 Apr 2018 – 27 Apr 2018Human Drugs483View 483 →
29 Feb 2016 – 2 Mar 2016Human DrugsClean
20 Dec 2012Not recordedClean
30 Apr 2009Not recorded483View 483 →
17 May 2001Not recordedClean

Observations on record

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

27 Apr 2018
21 CFR 211.160(b)

Scientifically sound laboratory controls

Cited by William J Leonard

27 Apr 2018
21 CFR 211.194(a)(2)

Suitability of testing methods verified

Cited by William J Leonard

27 Apr 2018
21 CFR 211.22(d)

Procedures not in writing, fully followed

Cited by William J Leonard

27 Apr 2018
21 CFR 211.68(a)

Calibration/Inspection/Checking not done

Cited by William J Leonard

30 Apr 2009
21 CFR 211.165(a)

Testing and release for distribution

Cited by Miguel A Martinez, Kevin P Foley

Investigators

FDA investigators tied to this site in the record.

MRA MunizN1 insp.
William J Leonard1 insp.
Torrance J Slayton1 insp.
Brittany D Terhar1 insp.
Miguel A Martinez1 insp.
Kevin P Foley1 insp.

Recurring citations

CFR citation patterns observed across this site's inspections.

CitationWhat it coversCited
21 CFR 211.160(b)Cited across public-safe Form 483 observations1x
21 CFR 211.165(a)Cited across public-safe Form 483 observations1x
21 CFR 211.194(a)Cited across public-safe Form 483 observations1x
21 CFR 211.194(a)(2)Cited across public-safe Form 483 observations1x
21 CFR 211.194(d)Cited across public-safe Form 483 observations1x
21 CFR 211.22(d)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 Takeda Ireland Limited's 2 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