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Valeant Canada Ltd.

⚠️ Moderate Risk

FEI: 3004889340 • Saint-laurent, Quebec • CANADA

FEI

FEI Number

3004889340

📍

Location

Saint-laurent, Quebec

🇨🇦

Country

CANADA
🏢

Address

4787 Levy St, , Saint-laurent, Quebec, Canada

Moderate Risk

FDA Import Risk Assessment

37.7
LowModerateHighCritical

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

Statistics

2
Total Refusals
2
Unique Violations
1/7/2012
Latest Refusal
5/14/2007
Earliest Refusal

Score Breakdown

Violation Severity
80.0×40%
Refusal Volume
17.7×30%
Recency
0.0×20%
Frequency
4.3×10%
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

3421×

PERSONALRX

The article appears to be a drug which requires a prescription from your doctor.

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
1/7/2012
63VIS02HYDROQUINONE (DEPIGMENTOR)
75UNAPPROVED
New Orleans District Office (NOL-DO)
5/14/2007
61MCA17NITRAZEPAM (ANTI-CONVULSANT)
342PERSONALRX
New York District Office (NYK-DO)

Frequently Asked Questions

What is Valeant Canada Ltd.'s FDA import refusal history?

Valeant Canada Ltd. (FEI: 3004889340) has 2 FDA import refusal record(s) in our database, spanning from 5/14/2007 to 1/7/2012.

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 Ltd.'s FEI number is 3004889340.

What types of violations has Valeant Canada Ltd. received?

Valeant Canada Ltd. has been cited for 2 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 Ltd. come from?

All FDA import refusal data for Valeant Canada Ltd. 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.