FDA-Inspected Site

DiaSorin Ireland Ltd.

3 FDA inspections are on record for DiaSorin Ireland Ltd. in Dublin, Ireland.

483· Form 483 issued

Dublin, Ireland · Last updated July 10, 2026

Overview

  • 3 FDA inspections are on record.
  • 1 inspection produced a Form 483.
  • The most recent recorded inspection date is 2014-04-10.

At a glance

Inspections

3

Form 483s

1

EIRs

0

Last outcome

Form 483

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
7 Apr 2014 – 10 Apr 2014Medical Devices & Rad Health483View 483 →
5 Jul 2012Not recordedClean
3 Jul 2008Not recordedClean

Observations on record

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

10 Apr 2014
21 CFR 820.30(i)

Design changes - Lack of or Inadequate Procedures

Cited by Dorothy W Lee

10 Apr 2014
21 CFR 820.50

Purchasing controls, Lack of or inadequate procedures

Cited by Dorothy W Lee

10 Apr 2014
21 CFR 820.100(a)

Lack of or inadequate procedures

Cited by Dorothy W Lee

10 Apr 2014
21 CFR 820.198(a)

Lack of or inadequate complaint procedures

Cited by Dorothy W Lee

Investigators

FDA investigators tied to this site in the record.

Thomas E Friel1 insp.

Recurring citations

CFR citation patterns observed across this site's inspections.

CitationWhat it coversCited
21 CFR 820.100(a)Cited across public-safe Form 483 observations1x
21 CFR 820.198(a)Cited across public-safe Form 483 observations1x
21 CFR 820.30(i)Cited across public-safe Form 483 observations1x
21 CFR 820.50Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind DiaSorin Ireland Ltd.'s 1 Form 483

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