ImportRefusal LogoImportRefusal

CARL ZEISS VISION CANADA, INC.

⚠️ Moderate Risk

FEI: 3007675955 • North York, Ontario • CANADA

FEI

FEI Number

3007675955

📍

Location

North York, Ontario

🇨🇦

Country

CANADA
🏢

Address

45 Valleybrook Dr, , North York, Ontario, Canada

Moderate Risk

FDA Import Risk Assessment

25.3
LowModerateHighCritical

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

Statistics

2
Total Refusals
2
Unique Violations
6/27/2013
Latest Refusal
11/14/2012
Earliest Refusal

Score Breakdown

Violation Severity
45.0×40%
Refusal Volume
17.7×30%
Recency
0.0×20%
Frequency
20.0×10%
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

2351×

NOT IMPACT

The article appears to not have impact-resistant lenses in accordance with 21 CFR 801.410.

3411×

REGISTERED

It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).

Refusal History

DateProductViolationsDivision
6/27/2013
86NJHLENS, SPECTACLE (PRESCRIPTION), FOR READING DISCOMFORT
235NOT IMPACT
Detroit District Office (DET-DO)
11/14/2012
86HQGLENS, SPECTACLE, NON-CUSTOM (PRESCRIPTION)
341REGISTERED
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is CARL ZEISS VISION CANADA, INC.'s FDA import refusal history?

CARL ZEISS VISION CANADA, INC. (FEI: 3007675955) has 2 FDA import refusal record(s) in our database, spanning from 11/14/2012 to 6/27/2013.

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. CARL ZEISS VISION CANADA, INC.'s FEI number is 3007675955.

What types of violations has CARL ZEISS VISION CANADA, INC. received?

CARL ZEISS VISION CANADA, INC. 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 CARL ZEISS VISION CANADA, INC. come from?

All FDA import refusal data for CARL ZEISS VISION 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.