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Valeant Canada Consumer Products

⚠️ Moderate Risk

FEI: 3010014857 • Richmond Hill, Ontario • CANADA

FEI

FEI Number

3010014857

📍

Location

Richmond Hill, Ontario

🇨🇦

Country

CANADA
🏢

Address

35 Fulton Way, , Richmond Hill, Ontario, Canada

Moderate Risk

FDA Import Risk Assessment

27.0
LowModerateHighCritical

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

Statistics

1
Total Refusals
3
Unique Violations
7/18/2014
Latest Refusal
7/18/2014
Earliest Refusal

Score Breakdown

Violation Severity
56.7×40%
Refusal Volume
11.2×30%
Recency
0.0×20%
Frequency
10.0×10%
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

23001×

DIETARYLBL

The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it is a dietary supplement that appears to be misbranded within the meaning of Section 403(s)(2)(B) of the FD&C Act in that the label or labeling fails to identify the product by using the term "dietary supplement", which term may be modified with the name of such an ingredient.

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.

751×

UNAPPROVED

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA).

Refusal History

DateProductViolationsDivision
7/18/2014
54FYA99HERBALS & BOTANICALS (NOT TEAS), N.E.C.
2300DIETARYLBL
482NUTRIT LBL
75UNAPPROVED
Seattle District Office (SEA-DO)

Frequently Asked Questions

What is Valeant Canada Consumer Products's FDA import refusal history?

Valeant Canada Consumer Products (FEI: 3010014857) has 1 FDA import refusal record(s) in our database, spanning from 7/18/2014 to 7/18/2014.

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. Valeant Canada Consumer Products's FEI number is 3010014857.

What types of violations has Valeant Canada Consumer Products received?

Valeant Canada Consumer Products 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 Valeant Canada Consumer Products come from?

All FDA import refusal data for Valeant Canada Consumer Products 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.