Atlas

FDA-Inspected Site

CATALENT U.K. SWINDON ZYDIS LIMITED

9 FDA inspections are on record for CATALENT U.K. SWINDON ZYDIS LIMITED in Swindon, United Kingdom.

Clean· No action indicated

Swindon, United Kingdom · Last updated July 10, 2026

Overview

  • 9 FDA inspections are on record.
  • 7 inspections produced a Form 483.
  • The most recent recorded inspection date is 2024-10-10.

At a glance

Inspections

9

Form 483s

7

EIRs

0

Last outcome

Clean

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
9 Oct 2024 – 10 Oct 2024Human DrugsClean
20 Aug 2018 – 23 Aug 2018Human Drugs483On file
19 Jul 2018 – 26 Jul 2018Biologics483On file
16 Apr 2018 – 20 Apr 2018Human Drugs483View 483 →
30 Aug 2016 – 6 Sep 2016Biologics483On file
8 Sep 2014 – 12 Sep 2014Human Drugs483View 483 →
18 Nov 2011Not recorded483View 483 →
20 Mar 2008Not recorded483On file
16 Jun 2006Not recordedClean

Observations on record

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

20 Apr 2018
21 CFR 211.160(b)

Scientifically sound laboratory controls

Cited by Rebecca E Dombrowski, William J Leonard

20 Apr 2018
21 CFR 211.192

No written record of investigation

Cited by Rebecca E Dombrowski, William J Leonard

20 Apr 2018
21 CFR 211.194(a)(2)

Suitability of testing methods verified

Cited by Rebecca E Dombrowski, William J Leonard

20 Apr 2018
21 CFR 211.67(b)

Written procedures not established/followed

Cited by Rebecca E Dombrowski, William J Leonard

12 Sep 2014
21 CFR 211.22(d)

Procedures not in writing, fully followed

Cited by Nicholas L Paulin

Investigators

FDA investigators tied to this site in the record.

MRA MunizN1 insp.
Yvins Dezan1 insp.
Youmin Wang1 insp.
Burnell M Henry1 insp.
Rebecca E Dombrowski1 insp.
William J Leonard1 insp.
Omotunde O Osunsanmi1 insp.
Nicholas L Paulin1 insp.
Satheesh Thomas1 insp.
Rebecca Parrilla1 insp.

Recurring citations

CFR citation patterns observed across this site's inspections.

CitationWhat it coversCited
21 CFR 211.192Cited across public-safe Form 483 observations2x
21 CFR 211.100(b)Cited across public-safe Form 483 observations1x
21 CFR 211.160(b)Cited across public-safe Form 483 observations1x
21 CFR 211.194(a)(2)Cited across public-safe Form 483 observations1x
21 CFR 211.198(a)Cited across public-safe Form 483 observations1x
21 CFR 211.22(d)Cited across public-safe Form 483 observations1x
21 CFR 211.28(a)Cited across public-safe Form 483 observations1x
21 CFR 211.67(b)Cited across public-safe Form 483 observations1x
21 CFR 211.68(a)Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind CATALENT U.K. SWINDON ZYDIS LIMITED's 7 Form 483s

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