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FDA Inspections, Warning Letters and Import Refusals: Australia

FDA has recorded 335 inspections of firms in Australia, 30 of them (9.0%) classified OAI. It has issued 50 warning letters to firms there and refused 3,300 import shipments. 109 firms in Australia are named on FDA import alerts.

OAI (Official Action Indicated) means FDA recommends regulatory and/or administrative action after an inspection. A warning letter is FDA's formal notice of significant violations. An import refusal is a shipment FDA refused entry to the United States.

All countries · Check one supplier with the free FDA compliance check.

By year

The last 10 calendar years (2017 to 2026, 2026 so far). FDA adds classified inspections and posts actions months after they happen, so recent years can still grow.

Australia: FDA inspections per year 2017: 21 inspections2120172018: 11 inspections1120182019: 18 inspections1820192020: 3 inspections320202021: 0 inspections020212022: 20 inspections2020222023: 21 inspections2120232024: 18 inspections1820242025: 22 inspections2220252026: 12 inspections122026
YearInspectionsOAIOAI shareWarning lettersImport refusals
202612216.7%2122
202522522.7%257
202418316.7%232
20232114.8%0175
20222015.0%0911
202100171
20203266.7%2113
201918211.1%186
20181119.1%269
201721314.3%1140

Latest OAI inspections

DateFacilityProduct type
Jun 18, 2026ENGENEIC PTYDrugs
Jun 9, 2026Parnell Manufacturing Pty, Ltd.Veterinary
Jul 25, 2025Tripak Pharmaceuticals Pty LtdDrugs
Jul 21, 2025Veganic SKN LimitedDrugs
Jul 21, 2025Antaria Pty. Ltd.Drugs
Apr 8, 2025Cosmetic Manufacturers (Aust) Pty Ltd.Drugs
Mar 21, 2025Steric Trading Pty LtdFood/Cosmetics
Sep 17, 2024Parnell Manufacturing Pty, Ltd.Veterinary
Jun 21, 2024Heliora Laboratories Pty Ltd.Drugs
May 23, 2024Micro-X Ltd.Devices
Nov 17, 2023Antaria Pty. Ltd.Drugs
Jun 17, 2022Heliora Laboratories Pty Ltd.Drugs
Mar 10, 2020ATP Science Pty LtdFood/Cosmetics
Mar 4, 2020BJP Laboratories Pty LtdFood/Cosmetics
May 31, 2019Heliora Laboratories Pty Ltd.Drugs
May 24, 2019Tismor Health And Wellness Pty LimitedDrugs
Dec 21, 2018Jurox Pty LtdVeterinary
Dec 13, 2017Jalco Cosmetics Pty Ltd.Drugs
Dec 8, 2017IDT Australia Ltd.Drugs
Mar 31, 2017Delta Laboratories Pty LtdDrugs
Jun 27, 2014Eurofins BioPharma Product Testing Australia Pty Ltd.Drugs
Mar 4, 2014Hospira Australia Pty Ltd.Drugs
Jan 22, 2013Philemon Pty LtdFood/Cosmetics
Jan 18, 2013Philemon Pty LtdFood/Cosmetics
Jan 9, 2013Flavour Makers Pty LtdFood/Cosmetics

Showing the latest 25 of 30.

Latest warning letters

DateFirmProduct typeFDA center
Feb 9, 2026Veganic SKN LimitedDrugsCDER
Feb 6, 2026Cosmetic Manufacturers (Aust) Pty Ltd.DrugsCDER
Oct 9, 2025Melcare Biomedical PtyDrugsCDER
Sep 18, 2025MEDIA NETWORKS SYDNEY PTY LIMITEDDrugsCDER
Aug 15, 2024MEDIA NETWORKS SYDNEY PTY LIMITEDDrugsCDER
Mar 22, 2024Antaria Pty. Ltd.DrugsCDER
Jun 9, 2021Natural Beauty Care Pty LtdDrugsCDER
Jun 19, 2020Vapor KingsTobaccoCTP
Jan 15, 2020Tismor Health And Wellness Pty LimitedDrugsCDER
Dec 6, 2019Heliora Laboratories Pty Ltd.DrugsCDER
May 23, 2018IDT Australia Ltd.DrugsCDER
May 18, 2018Jalco Cosmetics Pty Ltd.DrugsCDER
Dec 19, 2017Delta Laboratories Pty LtdDrugsCDER
Feb 24, 2016Http://Www.Smokesbymail.NetTobaccoCTP
Feb 3, 2016E Australia ConsortiumTobaccoCTP
Dec 21, 2015TFS MANUFACTURING PTY LTDDevicesCDRH
Aug 27, 2015Www.Cheapeucigarettes.ComTobaccoCTP
Aug 21, 2015Www.Onlycigs.NetTobaccoCTP
Aug 18, 2015Www.Usacigs.NetTobaccoCTP
Aug 7, 2015Www.Buy200Cigs.ComTobaccoCTP
Aug 7, 2015Www.Discount4Cigs.ComTobaccoCTP
Jun 4, 2015Http://Www.Cigbase.ComTobaccoCTP
May 29, 2015Privacy Protection Service INCTobaccoCTP
Apr 17, 2015Www.Smokercart.ComTobaccoCTP
Feb 19, 2015Www.Achase.NetTobaccoCTP

Showing the latest 25 of 50.

Search every letter by company with the FDA warning letter search.

Latest import refusals

DateFirmProduct category
Sep 9, 2026PHARMACY SMART COMPOUNDING CHEMIDrugs and Biologics
Sep 9, 2026PHARMACY SMART COMPOUNDING CHEMIDrugs and Biologics
Sep 8, 2026BJP Laboratories Pty LtdHuman Foods
Aug 26, 2026Southern Canning Pty LtdHuman Foods
Aug 13, 2026Delta Laboratories Pty LtdDrugs and Biologics
Aug 13, 2026Veganic SKN LimitedDrugs and Biologics
Aug 11, 2026Ellex Medical Pty Ltd.Devices
Aug 11, 2026BJP Laboratories Pty LtdHuman Foods
Jul 25, 2026Mega Lifesciences (Australia) Pty LtdHuman Foods
Jul 24, 2026Boehringer Ingelheim Pty LimitedDrugs and Biologics
Jul 24, 2026HOF AN HOUNDDrugs and Biologics
Jul 24, 2026HOF AN HOUNDDrugs and Biologics
Jul 24, 2026MSD ANIMAL HEALTHDrugs and Biologics
Jul 24, 2026AUSTRALIA BOEHRINGER INGELHEIM PDrugs and Biologics
Jul 24, 2026Boehringer Ingelheim Pty LimitedDrugs and Biologics
Jul 24, 2026HOF AN HOUNDDrugs and Biologics
Jul 24, 2026HOF AN HOUNDDrugs and Biologics
Jul 24, 2026Boehringer Ingelheim Pty LimitedDrugs and Biologics
Jul 24, 2026AUSTRALIA BOEHRINGER INGELHEIM PDrugs and Biologics
Jul 24, 2026HOF AN HOUNDDrugs and Biologics
Jul 24, 2026ZOETIS AUSTRALIADrugs and Biologics
Jul 24, 2026HOF AN HOUNDDrugs and Biologics
Jul 24, 2026HOF AN HOUNDDrugs and Biologics
Jul 24, 2026HOF AN HOUNDDrugs and Biologics
Jul 24, 2026HOF AN HOUNDDrugs and Biologics

Showing the latest 25 of 3,300.

Firms on FDA import alerts

PublishedFirmImport alertList
Mar 31, 2026Biopharm Australia Pty. Ltd.68-19red
Jan 8, 2026Antaria Pty. Ltd.66-40red
Jan 8, 2026Cosmetic Manufacturers (Aust) Pty Ltd.66-40red
Jan 8, 2026Veganic SKN Limited66-40red
Jul 17, 2025Watch And Grow Food Co.71-04red
Jul 11, 2025Steric Trading Pty Ltd54-14red
Jul 9, 2025MEDIA NETWORKS SYDNEY PTY LIMITED66-79red
Jul 9, 2025Steric Trading Pty Ltd99-39red
Jun 26, 2025U CHEWS AUSTRALIA71-04red
Jun 4, 2025AGRIFOODS AUSTRALIA PTY TLD99-08red
Apr 3, 2025Michael Pond Family Trust71-04red
Apr 3, 2025Naturally Australian Pet Care71-04red
Apr 1, 2025Dailis Pty Ltd T/A Natural Pet Treats Australia71-04red
Mar 31, 2025Cool Off Pty Ltd71-04red
Mar 17, 2025AtheroCare66-41red
Mar 17, 2025Cholrem Pty Ltd66-41red
Jul 31, 2024Homart Pharmaceuticals Pty. Ltd.99-39red
Jul 26, 2024Homart Pharmaceuticals Pty. Ltd.66-41red
Dec 12, 2023Zoetis Australia Pty Ltd68-19red
Nov 16, 2023Mainfreight Warehousing Dandenong South40-05red
Oct 16, 2023Better Breathing Devices Pty Ltd89-08red
Oct 16, 2023Value Plus Animal Health Care Pr68-19red
Sep 29, 2023PLANET LUXE OPERATIONS PTY LTD66-79red
Aug 2, 2023A.G.M. Foods Pty Ltd54-12red
Oct 28, 2022Heliora Laboratories Pty Ltd.66-40red

Showing the latest 25 of 109.

Most-inspected facilities

FacilityCityInspectionsOAILatest
Alphapharm Pty, Ltd.Carole Park80Jun 28, 2024
Parnell Manufacturing Pty, Ltd.Alexandria72Jun 9, 2026
IDT Australia Ltd.Boronia61Mar 28, 2025
Mayne Pharma International PTY LTDSalisbury South60Mar 21, 2025
Hospira Australia Pty Ltd.Mulgrave61Sep 2, 2022
Jurox Pty LtdRutherford52Jun 28, 2022
Seqirus Pty LtdParkville50Aug 16, 2016
Aus Systems Pty LtdAllenby Gardens40Jun 25, 2026
Australia Deloraine Dairy Pty. Ltd.Dandenong South40May 15, 2026
ARNA Pharma Pty., Ltd.Frenchs Forest40Oct 17, 2025
Uscom LimitedSydney40May 29, 2025
Fink Engineering Pty. Ltd.Warana40Jan 28, 2025
Go Medical Industries Pty., Ltd.Subiaco41Dec 10, 2024
Intertek Testing Services Australia Pty LtdWest Footscray41Nov 3, 2023
Eurofins Biopharma Product Testing Australia Pty. Ltd.Girraween40Nov 4, 2022

See each facility's Form 483 observations with the FDA 483 search.

Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.