Haleon US Inc., Lincoln, NE – FDA Inspections

Inspection records and compliance data for Haleon US Inc. in Lincoln, Nebraska. 13 FDA inspections on record (2 OAI), last inspected September 11, 2024.

Company Profile

This profile covers Haleon US Inc. based in Lincoln, Nebraska, United States.

FDA Inspection History

FDA inspections: 13
OAI: 2
VAI: 3
NAI: 8
Form 483s: 0
Warning letters: 0

First inspected April 9, 2009. Last inspected September 11, 2024.

Most cited issue areas

Procedures not in writing, fully followed4 inspections
Extent of discrepancy, failure investigations3 inspections
Procedure Deviations Recorded and Justified3 inspections

FDA inspections (13)

Date	Result	FDA center(s)	Insp. #
September 11, 2024	NAI	Foods & Cosmetics · Foodborne Biological Hazards	1229361
September 30, 2021	VAI	Human Drugs · Drug Quality Assurance	1153381
December 4, 2019	NAI	Foods & Cosmetics · Food Composition, Standards, Labeling and Econ	1117667
May 25, 2017	NAI	Foods & Cosmetics · Food Composition, Standards, Labeling and Econ	1013216
February 22, 2017	NAI	Human Drugs · Drug Quality Assurance	1008528
August 30, 2016	NAI	Foods & Cosmetics, Human Drugs · Food Composition, Standards, Labeling and Econ	987426
October 21, 2013	NAI	Animal Drugs & Feeds, Human Drugs · Drug Quality Assurance	852460
February 14, 2013	OAI	Animal Drugs & Feeds, Human Drugs · Drug Quality Assurance	820634
August 10, 2012	NAI	Animal Drugs & Feeds, Human Drugs · Drug Quality Assurance	794561
January 20, 2012	OAI	Animal Drugs & Feeds, Human Drugs · Drug Quality Assurance	763095
July 8, 2011	VAI	Human Drugs · Drug Quality Assurance	730856
April 16, 2010	VAI	Animal Drugs & Feeds, Human Drugs · Drug Quality Assurance	655735
April 9, 2009	NAI	Animal Drugs & Feeds, Foods & Cosmetics, Human Drugs · Food Composition, Standards, Labeling and Econ	583151