FDA-Inspected Site

Norbrook Laboratories Limited

15 FDA inspections are on record for Norbrook Laboratories Limited in Newry, United Kingdom.

483· Form 483 issued

Newry, United Kingdom · Last updated August 15, 2026

Overview

  • 15 FDA inspections are on record.
  • 12 inspections produced a Form 483.
  • The most recent recorded inspection date is 2026-06-05.

At a glance

Inspections

15

Form 483s

12

EIRs

0

Last outcome

Form 483

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
25 May 2026 – 5 Jun 2026Animal Drugs & Feeds483View 483 →
24 Mar 2025 – 4 Apr 2025Animal Drugs & Feeds483View 483 →
18 Mar 2024 – 29 Mar 2024Animal Drugs & Feeds483On file
4 Oct 2021 – 15 Oct 2021Animal Drugs & Feeds483View 483 →
20 Jan 2020 – 7 Feb 2020Not recordedClean
20 Jan 2020 – 7 Feb 2020Animal Drugs & Feeds483On file
20 Jan 2020 – 7 Feb 2020Animal Drugs & Feeds483View 483 →
20 Jan 2020 – 7 Feb 2020Animal Drugs & Feeds483On file
20 Jan 2020 – 7 Feb 2020Animal Drugs & Feeds483View 483 →
20 Jan 2020 – 7 Feb 2020Animal Drugs & Feeds483View 483 →
23 Jan 2020 – 7 Feb 2020Animal Drugs & Feeds483View 483 →
15 Jul 2019 – 26 Jul 2019Animal Drugs & Feeds483View 483 →

Observations on record

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

5 Jun 2026
21 CFR 211.100(a)

Absence of Written Procedures

Cited by Sandra A Boyd, WenNing Chan

5 Jun 2026
21 CFR 211.110(b)

In-process materials specifications testing

Cited by Sandra A Boyd, WenNing Chan

5 Jun 2026
21 CFR 211.113(b)

Procedures for sterile drug products

Cited by Sandra A Boyd, WenNing Chan

5 Jun 2026
21 CFR 211.113(b)

Validation lacking for sterile drug products

Cited by Sandra A Boyd, WenNing Chan

5 Jun 2026
21 CFR 211.166(a)(3)

Valid stability test methods

Cited by Sandra A Boyd, WenNing Chan

Investigators

FDA investigators tied to this site in the record.

Recurring citations

CFR citation patterns observed across this site's inspections.

CitationWhat it coversCited
21 CFR 211.100(a)Cited across public-safe Form 483 observations5x
21 CFR 211.68(b)Cited across public-safe Form 483 observations5x
21 CFR 211.100(b)Cited across public-safe Form 483 observations4x
21 CFR 211.166(a)Cited across public-safe Form 483 observations4x
21 CFR 211.192Cited across public-safe Form 483 observations4x
21 CFR 211.58Cited across public-safe Form 483 observations4x
21 CFR 211.101(d)Cited across public-safe Form 483 observations3x
21 CFR 211.113(b)Cited across public-safe Form 483 observations3x
21 CFR 211.22(d)Cited across public-safe Form 483 observations2x
21 CFR 211.42(c)(10)(iv)Cited across public-safe Form 483 observations2x
21 CFR 211.63Cited across public-safe Form 483 observations2x
21 CFR 211.67(a)Cited across public-safe Form 483 observations2x
21 CFR 211.110(b)Cited across public-safe Form 483 observations1x
21 CFR 211.160(b)Cited across public-safe Form 483 observations1x
21 CFR 211.166(a)(3)Cited across public-safe Form 483 observations1x
21 CFR 211.198(b)(2)Cited across public-safe Form 483 observations1x
21 CFR 211.42(c)(10)Cited across public-safe Form 483 observations1x
21 CFR 211.42(c)(10)(v)Cited across public-safe Form 483 observations1x
21 CFR 514.80(a)(1)Cited across public-safe Form 483 observations1x
21 CFR 514.80(b)(4)Cited across public-safe Form 483 observations1x
21 CFR 514.80(b)(4)(iv)(B)Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind Norbrook Laboratories Limited's 12 Form 483s

Source PDFs 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