FDA-Inspected Site

Haleon US Holdings LLC

13 FDA inspections are on record for Haleon US Holdings LLC in East Durham, United States.

Clean· No action indicated

East Durham, United States · Last updated August 15, 2026

Overview

  • 13 FDA inspections are on record.
  • 1 inspection produced a Form 483.
  • The most recent recorded inspection date is 2023-07-25.

At a glance

Inspections

13

Form 483s

1

EIRs

0

Last outcome

Clean

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
19 Jul 2023 – 25 Jul 2023Human DrugsClean
30 Aug 2018 – 11 Sep 2018Human Drugs483View 483 →
11 Feb 2014 – 12 Feb 2014Human DrugsClean
17 Sep 2013 – 19 Sep 2013Human DrugsClean
29 Jun 2012Not recordedClean
16 Dec 2009Not recordedClean
13 Mar 2008Not recordedClean
9 May 2007Not recordedClean
7 Dec 2005Not recordedClean
27 Apr 2005Not recordedClean
13 May 2003Not recordedClean
24 Oct 2002Not recordedClean

Observations on record

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

11 Sep 2018
21 CFR 211.110(a)

Control procedures to monitor and validate performance

Cited by Rajiv R Srivastava

11 Sep 2018
21 CFR 211.22(d)

Procedures not in writing, fully followed

Cited by Rajiv R Srivastava

Investigators

FDA investigators tied to this site in the record.

James A Liubicich2 insp.
Denise L Terzian1 insp.
Anne-Marie Dubrey1 insp.

Recurring citations

CFR citation patterns observed across this site's inspections.

CitationWhat it coversCited
21 CFR 211.110(a)Cited across public-safe Form 483 observations1x
21 CFR 211.22(d)Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind Haleon US Holdings LLC'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