CANADA
CANADA
FDA import refusal data for products from CANADA
Common Violations
Top Firms
| # | Firm Name | Risk | Refusals |
|---|---|---|---|
| 1 | Herbaland Naturals Inc Richmond | Risk: 86.6 | 208 |
| 2 | Bora Pharmaceutical Services Inc. Mississauga | Risk: 79.6 | 202 |
| 3 | NOVO NORDISK Mississauga | Risk: 89.3 | 193 |
| 4 | Omega Alpha Pharmaceuticals Scarborough | Risk: 73.2 | 184 |
| 5 | ITN Food Toronto | Risk: 78.2 | 175 |
| 6 | Terravita Brampton | Risk: 61.0 | 159 |
| 7 | Voortman Cookies Limited Burlington | Risk: 70.4 | 157 |
| 8 | Apotex Inc. North York | Risk: 84.2 | 151 |
| 9 | DION HERBS & SPICES Saint-Jerome | Risk: 74.5 | 140 |
| 10 | Risk: 89.1 | 132 | |
| 11 | Oliver Olives, Inc. Bolton | Risk: 57.5 | 132 |
| 12 | Apollo Health And Beauty Care, Inc. North York | Risk: 69.7 | 130 |
| 13 | Cargill Limited Clavet | Risk: 73.2 | 123 |
| 14 | Risk: 67.4 | 123 | |
| 15 | Pharma Exp Montreal | Risk: 62.4 | 112 |
| 16 | Larrearx Vancouver | Risk: 63.9 | 98 |
| 17 | Germiphene Corporation Brantford | Risk: 61.9 | 96 |
| 18 | Mineral Medix Solutions Inc. Richmond Hill | Risk: 69.0 | 94 |
| 19 | Risk: 61.0 | 92 | |
| 20 | Pharmascience Inc. Montreal | Risk: 75.4 | 91 |
Frequently Asked Questions
How many FDA import refusals are from CANADA?
According to FDA records, there have been 22,066 import refusals for products originating from CANADA, involving 5623 firms.
What products from CANADA are commonly refused by the FDA?
Products from CANADA may be refused for various reasons including adulteration, misbranding, lack of proper registration, or failure to meet U.S. safety standards. The specific products vary by firm and time period. View the common violations section on this page for more details.
Does an import refusal mean products from CANADA are unsafe?
Not necessarily. An import refusal indicates a specific shipment appeared to violate FDA requirements at the time of inspection. Many CANADA firms successfully import products that meet all FDA requirements. Import refusals help identify and prevent non-compliant products from entering the U.S. market.
How current is the FDA import refusal data for CANADA?
Our database includes FDA import refusals for CANADA through 12/29/2025. Data is sourced from the FDA Data Dashboard and updated monthly.
Data sourced from the FDA Data Dashboard, a public database maintained by the U.S. Food and Drug Administration.