FDA-Inspected Site

Almac Pharma Services Limited

8 FDA inspections are on record for Almac Pharma Services Limited in Craigavon, United Kingdom.

483· Form 483 issued

Craigavon, United Kingdom · Last updated August 15, 2026

Overview

  • 8 FDA inspections are on record.
  • 3 inspections produced a Form 483.
  • The most recent recorded inspection date is 2025-11-28.

At a glance

Inspections

8

Form 483s

3

EIRs

2

Last outcome

Form 483

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
24 Nov 2025 – 28 Nov 2025Human Drugs483View 483 →
16 Sep 2024Human DrugsClean
2 Sep 2019 – 6 Sep 2019Human DrugsClean
19 Jun 2017 – 23 Jun 2017Human Drugs483On file
18 May 2015 – 22 May 2015Human DrugsClean
19 Apr 2013 – 26 Apr 2013Human DrugsClean
27 Apr 2011Not recordedClean
15 May 2009Not recorded483On file

Observations on record

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

28 Nov 2025
21 CFR 211.100(a)

Absence of Written Procedures

Cited by Justin A Boyd, Khoa Nathan V Tran

28 Nov 2025
21 CFR 211.188

Prepared for each batch, include complete information

Cited by Justin A Boyd, Khoa Nathan V Tran

28 Nov 2025
21 CFR 211.192

Investigations of discrepancies, failures

Cited by Justin A Boyd, Khoa Nathan V Tran

28 Nov 2025
21 CFR 211.67(a)

Cleaning / Sanitizing / Maintenance

Cited by Justin A Boyd, Khoa Nathan V Tran

28 Nov 2025
21 CFR 211.68(b)

Computer control of master formula records

Cited by Justin A Boyd, Khoa Nathan V Tran

Investigators

FDA investigators tied to this site in the record.

MRA M BarbosaR1 insp.
Katherine Szestypalow1 insp.
Kevin P Foley1 insp.

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 observations1x
21 CFR 211.188Cited across public-safe Form 483 observations1x
21 CFR 211.192Cited across public-safe Form 483 observations1x
21 CFR 211.67(a)Cited across public-safe Form 483 observations1x
21 CFR 211.68(b)Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind Almac Pharma Services Limited's 3 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