Atlas

FDA-Inspected Site

Haleon US Inc.

20 FDA inspections are on record for Haleon US Inc. in Lincoln, United States.

Clean· No action indicated

Lincoln, United States · Last updated July 10, 2026

Overview

  • 20 FDA inspections are on record.
  • 6 inspections produced a Form 483.
  • The most recent recorded inspection date is 2024-09-11.

At a glance

Inspections

20

Form 483s

6

EIRs

0

Last outcome

Clean

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
10 Sep 2024 – 11 Sep 2024Foods & CosmeticsClean
20 Sep 2021 – 30 Sep 2021Human Drugs483View 483 →
3 Dec 2019 – 4 Dec 2019Foods & CosmeticsClean
21 Feb 2017 – 22 Feb 2017Human DrugsClean
22 Aug 2016 – 30 Aug 2016Human DrugsClean
15 Oct 2013 – 21 Oct 2013Human DrugsClean
28 Jan 2013 – 14 Feb 2013Human Drugs483View 483 →
10 Aug 2012Not recordedClean
20 Jan 2012Not recorded483View 483 →
8 Jul 2011Not recorded483View 483 →
24 May 2010Not recordedClean
16 Apr 2010Not recorded483View 483 →

Observations on record

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

30 Sep 2021
21 CFR 211.113(a)

Procedures for non-sterile drug products

Cited by Lisa L Flores, Sandra A Boyd, Jacob G Lutz

30 Sep 2021
21 CFR 211.166(a)(3)

Valid stability test methods

Cited by Lisa L Flores, Sandra A Boyd, Jacob G Lutz

30 Sep 2021
21 CFR 211.192

Investigations of discrepancies, failures

Cited by Lisa L Flores, Sandra A Boyd, Jacob G Lutz

30 Sep 2021
21 CFR 211.22(d)

Procedures not in writing, fully followed

Cited by Lisa L Flores, Sandra A Boyd, Jacob G Lutz

30 Sep 2021
21 CFR 211.67(b)

Written procedures not established/followed

Cited by Lisa L Flores, Sandra A Boyd, Jacob G Lutz

Investigators

FDA investigators tied to this site in the record.

Eric M Mueller6 insp.
Joseph R Lambert4 insp.
Veronica Fuentes2 insp.
Jessica E Hensley2 insp.
Kimberlee A Ewing1 insp.
Lisa L Flores1 insp.
Sandra A Boyd1 insp.
Jacob G Lutz1 insp.
Cody J Alley1 insp.
Susanna E Ford1 insp.
Thuy T Nguyen1 insp.
Adree N Anderson1 insp.
State Agency1 insp.
Shirley J Berryman1 insp.

Recurring citations

CFR citation patterns observed across this site's inspections.

CitationWhat it coversCited
21 CFR 211.192Cited across public-safe Form 483 observations10x
21 CFR 211.100(b)Cited across public-safe Form 483 observations4x
21 CFR 211.198(a)Cited across public-safe Form 483 observations4x
21 CFR 211.22(d)Cited across public-safe Form 483 observations4x
21 CFR 211.25(a)Cited across public-safe Form 483 observations2x
21 CFR 211.25(c)Cited across public-safe Form 483 observations2x
21 CFR 314.81(b)(1)(i)Cited across public-safe Form 483 observations2x
21 CFR 211.105(b)Cited across public-safe Form 483 observations1x
21 CFR 211.113(a)Cited across public-safe Form 483 observations1x
21 CFR 211.166(a)Cited across public-safe Form 483 observations1x
21 CFR 211.166(a)(3)Cited across public-safe Form 483 observations1x
21 CFR 211.170(b)Cited across public-safe Form 483 observations1x
21 CFR 211.180(e)(1)Cited across public-safe Form 483 observations1x
21 CFR 211.180(e)(2)Cited across public-safe Form 483 observations1x
21 CFR 211.182Cited across public-safe Form 483 observations1x
21 CFR 211.198(b)(2)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 211.94(b)Cited across public-safe Form 483 observations1x
21 CFR 314.81(b)(1)(ii)Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind Haleon US Inc.'s 6 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