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FDA Inspections, Warning Letters and Import Refusals: Canada

FDA has recorded 1,918 inspections of firms in Canada, 135 of them (7.0%) classified OAI. It has issued 173 warning letters to firms there and refused 22,880 import shipments. 843 firms in Canada 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.

Canada: FDA inspections per year 2017: 113 inspections11320172018: 74 inspections7420182019: 116 inspections11620192020: 45 inspections4520202021: 4 inspections420212022: 65 inspections6520222023: 103 inspections10320232024: 80 inspections8020242025: 87 inspections8720252026: 35 inspections352026
YearInspectionsOAIOAI shareWarning lettersImport refusals
20263500.0%8815
20258789.2%101,000
2024801012.5%8928
202310398.7%3658
2022651015.4%3532
20214125.0%5444
202045511.1%13697
201911643.4%11616
20187456.8%13477
201711387.1%7495

Latest OAI inspections

DateFacilityProduct type
Nov 3, 2025Jubilant HollisterStier General PartnershipVeterinary
Sep 5, 2025Keter Canada, Inc.Devices
Aug 28, 2025Northern Digital Inc.Devices
May 23, 2025SV Labs Toronto CorporationDrugs
May 16, 2025VitaCare Labs Inc.Drugs
May 9, 2025Apotex Inc.Drugs
Apr 25, 2025Innocore Sales & Marketing Inc.Drugs
Feb 14, 2025Laboratoires Druide Inc.Drugs
Oct 12, 2024Cosmaceutical Research Lab Inc.Drugs
Jun 21, 2024Brands International CorporationDrugs
Jun 14, 2024Jubilant HollisterStier General PartnershipDrugs
May 16, 2024Dr Ma's Laboratories, Inc.Food/Cosmetics
Apr 30, 2024Avaria Health & Beauty Corp.Drugs
Feb 9, 2024Innotech Nutrition Solutions, Ltd.Food/Cosmetics
Feb 7, 2024Nutralab Canada Corp.Food/Cosmetics
Jan 26, 2024HERBALAND NATURALS INCFood/Cosmetics
Jan 22, 2024Herbaland Naturals IncFood/Cosmetics
Jan 15, 2024HERBALAND NATURALS INCFood/Cosmetics
Dec 15, 2023Pillar5 Pharma Inc.Drugs
Nov 15, 2023Q-Pharm Inc.Veterinary
Oct 19, 2023Vegewax Candleworx Ltd.Drugs
Aug 18, 2023Les Importations Herbasante Inc.Drugs
Jun 22, 2023Techlem Medical CorporationDevices
Jun 8, 2023Trexo Robotics Holdings Inc.Devices
Mar 16, 2023CANADIAN GENERAL FILTERS LIMITEDDevices

Showing the latest 25 of 135.

Latest warning letters

DateFirmProduct typeFDA center
Oct 15, 2026Psyched Wellness Ltd.Food/CosmeticsCFSAN
Jun 17, 2026LEADING EDGE HEALTH INCDrugsCDER
Jun 5, 2026Jubilant HollisterStier General PartnershipDrugsCDER
Jun 5, 2026Sante Manufacturing Inc.DrugsCDER
Jun 2, 2026PLZ Corp.DrugsCDER
May 18, 2026Aja Therapeutics Inc.Food/CosmeticsCFSAN
Apr 17, 2026SaNOtize Wellness Corp.DrugsCDER
Apr 3, 2026Mohawksmoke.ComTobaccoCTP
Dec 12, 2025Nicmafia.ComTobaccoCTP
Oct 31, 2025Apotex Inc.DrugsCDER
Oct 17, 2025Vapes ATLTobaccoCTP
Oct 16, 2025Innocore Sales & Marketing Inc.DrugsCDER
Sep 9, 2025Canada Med StopDrugsCDER
Sep 9, 2025Cosmo Medical SpaDrugsCDER
Sep 9, 2025FWD Care, Inc.DrugsCDER
Aug 11, 2025Everlaan Organics IncDrugsCDER
May 29, 2025Laboratoires Druide Inc.DrugsCDER
Apr 4, 2025Dripcratevapeshop.ComTobaccoCTP
Dec 17, 2024Brands International CorporationDrugsCDER
Oct 29, 2024Packs PodTobaccoCTP
Sep 9, 2024EnviroServe Chemicals & Cleaners Ltd.DrugsCDER
Sep 3, 2024Avaria Health & Beauty Corp.DrugsCDER
Jun 14, 2024Vegewax Candleworx Ltd.DrugsCDER
Apr 30, 20242187954 ALBERTA INC.DrugsCDER
Mar 27, 2024Bodywell Natural Skin Care Inc.DrugsCDER

Showing the latest 25 of 173.

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

Latest import refusals

DateFirmProduct category
Oct 22, 2026Homeocan IncDrugs and Biologics
Oct 22, 2026TJP LABSTobacco Products
Oct 22, 2026WithinUs Natural Health IncHuman Foods
Oct 22, 2026WithinUs Natural Health IncHuman Foods
Oct 22, 2026WithinUs Natural Health IncHuman Foods
Oct 22, 2026A7 INTEGRATIONDevices
Oct 22, 2026A7 INTEGRATIONDevices
Oct 21, 2026SUN PHARMACEUTICALS INDUSTRIESDrugs and Biologics
Oct 21, 2026Bayer IncorporatedDrugs and Biologics
Oct 21, 2026Teva Canada LimitedDrugs and Biologics
Oct 21, 2026WithinUs Natural Health IncHuman Foods
Oct 21, 2026WithinUs Natural Health IncHuman Foods
Oct 21, 2026WithinUs Natural Health IncHuman Foods
Oct 21, 2026WithinUs Natural Health IncHuman Foods
Oct 21, 2026WithinUs Natural Health IncHuman Foods
Oct 21, 2026WithinUs Natural Health IncHuman Foods
Oct 21, 2026WithinUs Natural Health IncHuman Foods
Oct 21, 2026WithinUs Natural Health IncHuman Foods
Oct 21, 2026WithinUs Natural Health IncHuman Foods
Oct 21, 2026WithinUs Natural Health IncHuman Foods
Oct 21, 2026WithinUs Natural Health IncHuman Foods
Oct 21, 2026WithinUs Natural Health IncHuman Foods
Oct 21, 2026WithinUs Natural Health IncHuman Foods
Oct 21, 2026WithinUs Natural Health IncHuman Foods
Oct 21, 2026WithinUs Natural Health IncHuman Foods

Showing the latest 25 of 22,880.

See every import refusal from Canada.

Firms on FDA import alerts

PublishedFirmImport alertList
Oct 26, 2026Efcon Imports45-02red
Sep 28, 2026Hanifs International Foods Ltd99-53red
Sep 28, 2026Rubicon Food Prod99-53red
Sep 25, 2026Naturo Aid Pharmaceutical Inc.66-41red
Sep 23, 2026Naturo Aid Pharmaceutical Inc.99-39red
Sep 23, 2026VITA AID99-39red
Aug 26, 20261710709 ONTARIO INC OA DA PRODUCE GUYS99-05red
Aug 26, 2026EVERFRESH GREENHOUSE (SEE 12694699-05red
Aug 17, 20261001387362 Ontario Inc54-15red
Jul 27, 20268546924 CANADA INC.45-02red
Jul 7, 2026Vinaya Enterprise Inc99-08red
Jun 23, 2026MILLGROVE FARMS SALES INC99-05red
Jun 12, 2026ECHO SALES AMERICA45-02red
May 26, 2026PepsiCo Foods Canada Cambridge45-02red
May 18, 2026Only Fresh Food Inc.99-08red
May 13, 2026Les Pecheries Gaspesienne Inc16-39red
May 8, 2026SHEFFINGTON SUPPLY CO - MIGUEL HQ45-02red
Apr 27, 2026Sante Manufacturing Inc.66-40red
Apr 24, 2026H&M Farms Ltd99-05red
Apr 17, 2026Crystal Claire Cosmetics Inc.53-06red
Apr 16, 2026PATISSERIE NOISETTINE45-02red
Apr 14, 2026MONETTE FARMS99-05red
Apr 14, 2026MONETTE PRODUCE LTD99-05red
Apr 14, 2026Patisserie Orientale Sweets45-02red
Mar 31, 2026BC Fresh Vegetables99-05red

Showing the latest 25 of 843.

Most-inspected facilities

FacilityCityInspectionsOAILatest
Apotex Inc.North York112Sep 25, 2026
Apotex Inc.Richmond Hill112May 9, 2025
Pillar5 Pharma Inc.Arnprior101Jun 5, 2026
Jubilant HollisterStier General PartnershipKirkland104Nov 3, 2025
Bora Pharmaceutical Services Inc.Mississauga100Jan 28, 2025
Novocol Pharmaceutical Of Canada, Inc.Cambridge100May 3, 2024
Apotex, Inc.Etobicoke91Sep 27, 2024
Bausch Health Companies Inc.Laval90Jan 19, 2024
BWXT Medical Ltd.Ottawa90Mar 3, 2023
Ropack, Inc. (Site A & B)Anjou91Jun 17, 2022
Apollo Health And Beauty Care, Inc.North York82Mar 20, 2026
Voyant Beauty, Inc.Etobicoke80May 30, 2025
ID Biomedical Corporation Of QuebecQuebec81Mar 28, 2025
Confab Laboratories Inc.Saint-Hubert80Feb 21, 2025
Abbott Point Of Care Canada LimitedNepean81Sep 19, 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.