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CANADA

CANADA

FDA import refusal data for products from CANADA

5640
Total Firms
22,172
Total Refusals
1/22/2026
Latest Refusal

Common Violations

6166

UNAPPROVED

3425

NOT LISTED

2840

NUTRIT LBL

1209

LIST INGRE

1164

LABELING

1120

FRNMFGREG

969

UNSAFE COL

927

LACKS N/C

922

NO 510(K)

10249
764

FILTHY

Top Firms

#Firm NameRiskRefusals
1Risk: 86.6208
2Risk: 79.6202
3
NOVO NORDISK

Mississauga

Risk: 89.3199
4Risk: 73.2184
5
ITN Food

Toronto

Risk: 78.0175
6
Terravita

Brampton

Risk: 61.0159
7Risk: 70.4157
8
Apotex Inc.

North York

Risk: 84.0151
9Risk: 74.5140
10Risk: 89.1132
11Risk: 57.5132
12Risk: 69.7130
13Risk: 73.2123
14Risk: 67.4123
15
Pharma Exp

Montreal

Risk: 62.4112
16
Larrearx

Vancouver

Risk: 63.998
17Risk: 61.996
18Risk: 69.094
19Risk: 61.092
20Risk: 75.492

Frequently Asked Questions

How many FDA import refusals are from CANADA?

According to FDA records, there have been 22,172 import refusals for products originating from CANADA, involving 5640 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 1/22/2026. 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.