Atlas

FDA-Inspected Site

Jurox Pty. Limited

7 FDA inspections are on record for Jurox Pty. Limited in Rutherford, Australia.

483· Form 483 issued

Rutherford, Australia · Last updated August 15, 2026

Overview

  • 7 FDA inspections are on record.
  • 6 inspections produced a Form 483.
  • The most recent recorded inspection date is 2022-06-28.

At a glance

Inspections

7

Form 483s

6

EIRs

0

Last outcome

Form 483

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
20 Jun 2022 – 28 Jun 2022Animal Drugs & Feeds483View 483 →
10 Dec 2018 – 21 Dec 2018Animal Drugs & Feeds483View 483 →
17 Sep 2015 – 25 Sep 2015Animal Drugs & Feeds483View 483 →
4 Nov 2011Not recorded483On file
11 Nov 2010Not recorded483On file
6 Jun 2008Not recordedClean
26 Feb 2008Not recorded483On file

Observations on record

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

28 Jun 2022
21 CFR 211.100(a)

Absence of Written Procedures

Cited by Jolanna A Norton

28 Jun 2022
21 CFR 211.22(d)

Procedures not in writing, fully followed

Cited by Jolanna A Norton

21 Dec 2018
21 CFR 11

Electronic records

Cited by Claire M Minden

21 Dec 2018
21 CFR 211.166(a)(3)

Valid stability test methods

Cited by Claire M Minden

21 Dec 2018
21 CFR 211.170(b)

Annual visual exams of drug products

Cited by Claire M Minden

Investigators

FDA investigators tied to this site in the record.

Jolanna A Norton1 insp.
Claire M Minden1 insp.
Jennifer M Gogley1 insp.
Stephen D Brown1 insp.
Kham Phommachanh1 insp.
Parul M Patel1 insp.
Uttaniti Limchumroon1 insp.
Lloyd D Payne1 insp.
Ann L Demarco1 insp.
Brenda W Uratani1 insp.

Recurring citations

CFR citation patterns observed across this site's inspections.

CitationWhat it coversCited
21 CFR 211.113(b)Cited across public-safe Form 483 observations4x
21 CFR 211.166(a)(3)Cited across public-safe Form 483 observations4x
21 CFR 211.170(b)Cited across public-safe Form 483 observations4x
21 CFR 211.192Cited across public-safe Form 483 observations4x
21 CFR 211.84(d)(2)Cited across public-safe Form 483 observations4x
21 CFR 11Cited across public-safe Form 483 observations2x
21 CFR 211.160(a)Cited across public-safe Form 483 observations2x
21 CFR 211.166(a)Cited across public-safe Form 483 observations2x
21 CFR 211.180(e)(2)Cited across public-safe Form 483 observations2x
21 CFR 211.198(a)Cited across public-safe Form 483 observations2x
21 CFR 211.198(b)(1)Cited across public-safe Form 483 observations2x
21 CFR 211.22(c)Cited across public-safe Form 483 observations2x
21 CFR 211.42(b)Cited across public-safe Form 483 observations2x
21 CFR 211.42(c)Cited across public-safe Form 483 observations2x
21 CFR 211.42(c)(10)(iv)Cited across public-safe Form 483 observations2x
21 CFR 211.67(b)Cited across public-safe Form 483 observations2x
21 CFR 211.68(a)Cited across public-safe Form 483 observations2x
21 CFR 211.100(a)Cited across public-safe Form 483 observations1x
21 CFR 211.22(d)Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind Jurox Pty. Limited's 6 Form 483s

Source PDFs, 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