ImportRefusal LogoImportRefusal

Isotech Design Canada, Inc.

⚠️ Moderate Risk

FEI: 3007303662 • Saint-laurent, Quebec • CANADA

FEI

FEI Number

3007303662

📍

Location

Saint-laurent, Quebec

🇨🇦

Country

CANADA
🏢

Address

5778 Thimens Blvd, , 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

3
Total Refusals
1
Unique Violations
7/20/2004
Latest Refusal
7/20/2004
Earliest Refusal

Score Breakdown

Violation Severity
70.0×40%
Refusal Volume
22.3×30%
Recency
0.0×20%
Frequency
30.0×10%
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

4793×

DV QUALITY

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be adulterated since its strength differs from, or its purity or quality falls below, that which it purports or is represented to possess.

Refusal History

DateProductViolationsDivision
7/20/2004
80LYZGLOVE, PATIENT EXAMINATION, VINYL
479DV QUALITY
New York District Office (NYK-DO)
7/20/2004
80LYZGLOVE, PATIENT EXAMINATION, VINYL
479DV QUALITY
New York District Office (NYK-DO)
7/20/2004
80LYZGLOVE, PATIENT EXAMINATION, VINYL
479DV QUALITY
New York District Office (NYK-DO)

Frequently Asked Questions

What is Isotech Design Canada, Inc.'s FDA import refusal history?

Isotech Design Canada, Inc. (FEI: 3007303662) has 3 FDA import refusal record(s) in our database, spanning from 7/20/2004 to 7/20/2004.

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. Isotech Design Canada, Inc.'s FEI number is 3007303662.

What types of violations has Isotech Design Canada, Inc. received?

Isotech Design Canada, Inc. 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 Isotech Design Canada, Inc. come from?

All FDA import refusal data for Isotech Design 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.