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•United Kingdom

Norbrook Laboratories Limited, Newry, United Kingdom – FDA Inspections

Inspection records and compliance data for Norbrook Laboratories Limited in Newry. 15 FDA inspections on record (4 OAI), 4 Form 483s, last inspected June 05, 2026.

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Company Profile

This profile covers Norbrook Laboratories Limited based in Newry, United Kingdom.

FDA Inspection History

FDA inspections
15
OAI
4
VAI
2
NAI
6
Unclassified
3
Form 483s
4
Warning letters
0

First inspected February 3, 2010. Last inspected June 5, 2026.

Most cited issue areas

  • Absence of Written Procedures2 inspections
  • Cleaning / Sanitizing / Maintenance2 inspections
  • Environmental Monitoring System2 inspections

FDA inspections (15)

DateResultFDA center(s)Insp. #
June 5, 2026Not classifiedAnimal Drugs & Feeds · Monitoring of Marketed Animal Drugs, Feed, and Devices1321402
April 4, 2025Not classifiedAnimal Drugs & Feeds · Monitoring of Marketed Animal Drugs, Feeds, and Devices1266165
March 29, 2024OAIAnimal Drugs & Feeds · Pre-Approval Eval. of Animal Drugs and Food Additives1236307
October 15, 2021VAIAnimal Drugs & Feeds · Monitoring of Marketed Animal Drugs, Feed, and Devices1155086
February 7, 2020OAIAnimal Drugs & Feeds · Monitoring of Marketed Animal Drugs, Feed, and Devices1117113
July 26, 2019VAIAnimal Drugs & Feeds · Pre-Approval Eval. of Animal Drugs and Food Additives1098340
April 18, 2019OAIAnimal Drugs & Feeds · Monitoring of Marketed Animal Drugs, Feed, and Devices1086693
September 7, 2018NAIAnimal Drugs & Feeds · Monitoring of Marketed Animal Drugs, Feed, and Devices1070719
February 10, 2017Not classifiedAnimal Drugs & Feeds1009377
March 4, 2016NAIAnimal Drugs & Feeds · Pre-Approval Eval. of Animal Drugs and Food Additives960695
March 3, 2016NAIAnimal Drugs & Feeds · Pre-Approval Eval. of Animal Drugs and Food Additives960699
June 12, 2014NAIAnimal Drugs & Feeds · Pre-Approval Eval. of Animal Drugs and Food Additives887237
February 10, 2012OAIAnimal Drugs & Feeds · Pre-Approval Eval. of Animal Drugs and Food Additives779893
February 11, 2010NAIAnimal Drugs & Feeds · Pre-Approval Eval. of Animal Drugs and Food Additives649439
February 3, 2010NAIAnimal Drugs & Feeds · Monitoring of Marketed Animal Drugs, Feed, and Devices650440
FDA documents

Form 483s (4)

  • Form 483s · April 4, 2025
  • Form 483s · March 29, 2024
  • Form 483s · October 15, 2021
  • Form 483s · July 26, 2019
Other regulators (1)
  • UK MHRA · 2 inspections · last September 22, 2014
People (6)
Hugh M. McClure III
Person
Dawn C. Olenjack
Person
Roger F. Zabinski
Person
Jennifer L. Huntington
Person
Khoa Nathan V. Tran
Person
Tamil Arasu
Person
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Gallant Pet Incorporated
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KVP Pharma Veterin Produkte GmbH
Argenta US Manufacturing LLC
Centaur Inc
Company Information

Name

Norbrook Laboratories Limited

FEI Number

3005587188

Address

Carnbane Industrial Estate, Newry, United Kingdom

Country

United Kingdom

ID: c9294f28-e127-43a0-b824-82a6f41fabfd

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