ImportRefusal LogoImportRefusal

Coopervision Inc

⚠️ Moderate Risk

FEI: 1000437328 • Markham, ON • CANADA

FEI

FEI Number

1000437328

📍

Location

Markham, ON

🇨🇦

Country

CANADA
🏢

Address

100 Mcpherson, , Markham, ON, Canada

Moderate Risk

FDA Import Risk Assessment

32.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
12/14/2004
Latest Refusal
12/14/2004
Earliest Refusal

Score Breakdown

Violation Severity
70.0×40%
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

841×

RX DEVICE

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a prescription device that appears to not feature a prescription device legend as required by 21 CFR 801.109.

Refusal History

DateProductViolationsDivision
12/14/2004
86LPMLENSES, SOFT CONTACT, EXTENDED WEAR
84RX DEVICE
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is Coopervision Inc's FDA import refusal history?

Coopervision Inc (FEI: 1000437328) has 1 FDA import refusal record(s) in our database, spanning from 12/14/2004 to 12/14/2004.

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. Coopervision Inc's FEI number is 1000437328.

What types of violations has Coopervision Inc received?

Coopervision 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 Coopervision Inc come from?

All FDA import refusal data for Coopervision 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.