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Fortius Canada Inc

⚠️ Moderate Risk

FEI: 3003811259 • Charlottetown, PE • CANADA

FEI

FEI Number

3003811259

📍

Location

Charlottetown, PE

🇨🇦

Country

CANADA
🏢

Address

45 Maple Hills Ave Pe, , Charlottetown, PE, Canada

Moderate Risk

FDA Import Risk Assessment

31.3
LowModerateHighCritical

This firm has a moderate history of FDA import refusals. Some attention may be warranted.

Statistics

2
Total Refusals
3
Unique Violations
6/25/2008
Latest Refusal
5/14/2008
Earliest Refusal

Score Breakdown

Violation Severity
60.0×40%
Refusal Volume
17.7×30%
Recency
0.0×20%
Frequency
20.0×10%
How is this score calculated?

Proprietary Algorithm

  • 40% Violation Severity — AI-assessed (1-10)
  • 30% Refusal Volume — Logarithmic scale
  • 20% Recency — Decays over 5 years
  • 10% Frequency — Refusals per year

© ImportRefusal.com Original Analysis

Violation Summary

2601×

FALSE

The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(a)(1 ) of the FD&C Act in that the labeling is false or misleading in any particular.

33001×

ALLERGEN

the label fails to declare all major food allergens present in the product, as required by section 403(w)(1).

4821×

NUTRIT LBL

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded in that the label or labeling fails to bear the required nutrition information.

Refusal History

DateProductViolationsDivision
6/25/2008
54YCE07BIOFLAVANOIDS (VIT/MIN?PROTEIN/UNCONVENTIONAL DIETARY SPEC FOR HUMAN/ANIMAL, N.E.C.)
260FALSE
New York District Office (NYK-DO)
5/14/2008
54CCY99PROTEIN N.E.C.
3300ALLERGEN
482NUTRIT LBL
New England District Office (NWE-DO)

Frequently Asked Questions

What is Fortius Canada Inc's FDA import refusal history?

Fortius Canada Inc (FEI: 3003811259) has 2 FDA import refusal record(s) in our database, spanning from 5/14/2008 to 6/25/2008.

What is an FEI number?

FEI stands for Firm Establishment Identifier. It's a unique number assigned by the FDA to identify establishments that manufacture, process, pack, or hold food, drugs, medical devices, or other FDA-regulated products. Fortius Canada Inc's FEI number is 3003811259.

What types of violations has Fortius Canada Inc received?

Fortius Canada Inc has been cited for 3 different violation type(s). Common FDA violations include adulteration (unsafe or unsanitary products), misbranding (incorrect or misleading labels), and regulatory non-compliance.

Where does this information about Fortius Canada Inc come from?

All FDA import refusal data for Fortius Canada Inc is sourced from the official FDA Data Dashboard (datadashboard.fda.gov), a public government database maintained by the U.S. Food and Drug Administration.

Data sourced from the FDA Data Dashboard, a public database maintained by the U.S. Food and Drug Administration.