ImportRefusal LogoImportRefusal

Wamex Diagnostics

⚠️ Moderate Risk

FEI: 3004948405 • Laval, QC • CANADA

FEI

FEI Number

3004948405

📍

Location

Laval, QC

🇨🇦

Country

CANADA
🏢

Address

3885 Boul Industrial, , Laval, QC, 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
10/24/2005
Latest Refusal
10/24/2005
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

1861×

INSANITARY

The article is subject to refusal of admission pursuant to section 801(a)(3) in that the article appears to have been prepared, packed, or held under insanitary conditions whereby it may have been contaminated with filth, or whereby it may have been rendered injurious to health.

Refusal History

DateProductViolationsDivision
10/24/2005
57YY99BIOLOGICAL IN-VIVO AND IN-VITRO DIAGNOSTICS, N.E.C.
186INSANITARY
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is Wamex Diagnostics's FDA import refusal history?

Wamex Diagnostics (FEI: 3004948405) has 1 FDA import refusal record(s) in our database, spanning from 10/24/2005 to 10/24/2005.

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. Wamex Diagnostics's FEI number is 3004948405.

What types of violations has Wamex Diagnostics received?

Wamex Diagnostics 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 Wamex Diagnostics come from?

All FDA import refusal data for Wamex Diagnostics 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.