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Roche Canada

⚠️ Moderate Risk

FEI: 3005032659 • Montreal, QUEBEC • CANADA

FEI

FEI Number

3005032659

📍

Location

Montreal, QUEBEC

🇨🇦

Country

CANADA
🏢

Address

12109 16 East Ave, , Montreal, QUEBEC, Canada

Moderate Risk

FDA Import Risk Assessment

40.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
3/28/2008
Latest Refusal
3/28/2008
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
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

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
3/28/2008
62GIA50NAPROXEN SODIUM (ANTI-INFLAMMATORY)
75UNAPPROVED
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is Roche Canada's FDA import refusal history?

Roche Canada (FEI: 3005032659) has 1 FDA import refusal record(s) in our database, spanning from 3/28/2008 to 3/28/2008.

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. Roche Canada's FEI number is 3005032659.

What types of violations has Roche Canada received?

Roche Canada has been cited for 1 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 Roche Canada come from?

All FDA import refusal data for Roche Canada 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.