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FDA Inspections, Warning Letters and Import Refusals: New Zealand

FDA has recorded 77 inspections of firms in New Zealand, 6 of them (7.8%) classified OAI. It has issued 9 warning letters to firms there and refused 852 import shipments. 46 firms in New Zealand 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.

New Zealand: FDA inspections per year 2017: 7 inspections720172018: 1 inspections120182019: 4 inspections420192020: 3 inspections320202021: 0 inspections020212022: 3 inspections320222023: 12 inspections1220232024: 11 inspections1120242025: 6 inspections620252026: 1 inspections12026
YearInspectionsOAIOAI shareWarning lettersImport refusals
2026100.0%021
20256466.7%121
20241100.0%09
20231200.0%018
2022300.0%112
202100028
2020300.0%213
2019400.0%014
2018100.0%095
2017700.0%027

Latest OAI inspections

DateFacilityProduct type
Sep 26, 2025Synlait Milk LimitedFood/Cosmetics
May 21, 2025Miers Laboratories Ltd.Drugs
Apr 4, 2025BLIS Technologies LimitedFood/Cosmetics
Mar 28, 2025Xtend-Life Group LimitedFood/Cosmetics
Jul 10, 2014Jaychem Industries LtdDrugs
Dec 2, 2009Molteno Ophthalmic LimitedDevices

Latest warning letters

DateFirmProduct typeFDA center
Nov 3, 2025Miers Laboratories Ltd.DrugsCDER
Aug 19, 2022Mixology Ltd D.B.A. Mixology VapeTobaccoCTP
Sep 2, 2020Thomas MedsDrugsCDER
Jul 31, 2020Crafty E-Liquids LimitedTobaccoCTP
Sep 4, 2015Jaychem Industries LtdDrugsCDER
Feb 27, 2015Molteno Ophthalmic LimitedDevicesCDRH
Jun 2, 2010Fludefence.OrgFood/CosmeticsCFSAN
May 11, 2010Molteno Ophthalmic LimitedDevicesCDRH
May 14, 2009Resolveswineflu.Com USAFood/CosmeticsCFSAN

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

Latest import refusals

DateFirmProduct category
Oct 6, 2026ENDEAVOUR CONSUMER HEALTH LTDCosmetics
Sep 18, 2026ENDEAVOUR CONSUMER HEALTH LTDCosmetics
Sep 18, 2026ENDEAVOUR CONSUMER HEALTH LTDCosmetics
Sep 18, 2026ENDEAVOUR CONSUMER HEALTH LTDCosmetics
Sep 18, 2026ENDEAVOUR CONSUMER HEALTH LTDCosmetics
Sep 15, 2026ENDEAVOUR CONSUMER HEALTH LTDCosmetics
Sep 15, 2026ENDEAVOUR CONSUMER HEALTH LTDCosmetics
Aug 24, 2026ENDEAVOUR CONSUMER HEALTH LTDCosmetics
Jun 26, 2026Proliant New ZealandHuman Foods
Jun 8, 2026Fort Richard Laboratories LtdDrugs and Biologics
May 8, 2026Xtend-Life Group LimitedHuman Foods
May 8, 2026Xtend-Life Group LimitedHuman Foods
Apr 3, 2026ASPEN PHARMACY RETAILING NZ LTDDrugs and Biologics
Apr 3, 2026VIATRIS LTDDrugs and Biologics
Apr 3, 2026Aft Pharmaceuticals LimitedDrugs and Biologics
Apr 3, 2026Bayer New ZealandDrugs and Biologics
Apr 3, 2026DOUGLAS PHARMACEUTICALS LTDDrugs and Biologics
Apr 3, 2026MULTICHEM NEW ZEALANDHuman Foods
Apr 3, 2026TEVA PHARMA NZ LTDDrugs and Biologics
Jan 13, 2026Xtend-Life Group LimitedHuman Foods
Jan 13, 2026Xtend-Life Group LimitedHuman Foods
Dec 16, 2025CO-DHL AIRPARK GETZDevices
Oct 6, 2025Deep Blue Health New Zealand LimitedHuman Foods
Oct 6, 2025Deep Blue Health New Zealand LimitedHuman Foods
Oct 6, 2025Deep Blue Health New Zealand LimitedHuman Foods

Showing the latest 25 of 852.

Firms on FDA import alerts

PublishedFirmImport alertList
Dec 11, 2025ENDEAVOUR CONSUMER HEALTH LTD66-41red
Oct 27, 2025Miers Laboratories Ltd.66-40red
Aug 14, 2025BLIS Technologies Limited99-39red
Apr 1, 2025Dairy Meats Nz Limited71-04red
Apr 1, 2025Dairy Meats Of New Zealand Ltd.71-04red
May 2, 2023Claridges Organic Limited99-47red
Sep 1, 2020NRG Group Limited66-41red
Sep 1, 2020Nrg Group Ltd66-41red
May 16, 2019NRG Group Limited99-39red
Mar 18, 2019South Pacific Sera Limited68-19red
Jun 13, 2018Honey Collection Ltd89-08red
Jun 6, 2018Honey Collection Ltd68-19red
Dec 13, 2016Nrg Group Ltd99-39red
May 13, 2015Healtheries Of New Zealand Limited66-41red
Mar 6, 2015Aroma (NZ) Limited16-02green
Dec 22, 2014Jaychem Industries Ltd66-40red
Dec 10, 2014South Pacific Sera Limited68-19red
Mar 10, 2014Honey Collection Ltd66-41red
Dec 5, 2013Antipodes Nature Ltd66-41red
May 30, 2013Moana Pacific Fisheries16-04red
May 30, 2013SEI Limited16-04red
Jan 16, 2013Evergreen Life Limited66-41red
May 25, 2012Atmor Sales And Marketing66-41red
May 25, 2012Atmor Sales & Marketing Ltd66-41red
May 25, 2012Natural Solutions66-41red

Showing the latest 25 of 46.

Most-inspected facilities

FacilityCityInspectionsOAILatest
Douglas Manufacturing LimitedAuckland60May 30, 2025
Molteno Ophthalmic LimitedDunedin51Dec 18, 2024
Synlait Milk LimitedRakaia41Jun 8, 2026
DEC International NZ, Ltd.Hamilton40Oct 28, 2022
Argenta LimitedAuckland40Sep 20, 2019
Miers Laboratories Ltd.Lower Hutt31May 21, 2025
New Zealand Pharmaceutical Ltd.Palmerston North30May 16, 2025
Zenith Technology Corporation, Ltd.Dunedin30Apr 28, 2023
South Pacific Sera LimitedTimaru30Dec 1, 2016
Synlait Milk LimitedAuckland20Sep 20, 2024
Andrew Holden, M.D.Auckland20Apr 7, 2017
Fisher & Paykel Healthcare, Ltd.Auckland20Apr 5, 2013
BLIS Technologies LimitedDunedin11Apr 4, 2025
Xtend-Life Group LimitedChristchurch11Mar 28, 2025
Barnaby Henare Montgomery, M.D.Auckland10May 10, 2024

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.