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Contour Optik Inc

✅ Low Risk

FEI: 3004744558 • Wenzhouwenzhou • CHINA

FEI

FEI Number

3004744558

📍

Location

Wenzhouwenzhou

🇨🇳

Country

CHINA
🏢

Address

6 Lou No, Dong Da Streetlou Qiao; Town Ou, Wenzhouwenzhou, , China

Low Risk

FDA Import Risk Assessment

23.8
LowModerateHighCritical

This firm has a minimal history of FDA import refusals with low-severity violations.

Statistics

4
Total Refusals
1
Unique Violations
10/1/2014
Latest Refusal
6/3/2014
Earliest Refusal

Score Breakdown

Violation Severity
30.0×40%
Refusal Volume
25.9×30%
Recency
0.0×20%
Frequency
40.0×10%
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

3414×

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
10/1/2014
86NJHLENS, SPECTACLE (PRESCRIPTION), FOR READING DISCOMFORT
341REGISTERED
Florida District Office (FLA-DO)
8/22/2014
86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)
341REGISTERED
Division of Southeast Imports (DSEI)
8/22/2014
86HOISPECTACLE, MAGNIFYING
341REGISTERED
Division of Southeast Imports (DSEI)
6/3/2014
86HOISPECTACLE, MAGNIFYING
341REGISTERED
Florida District Office (FLA-DO)

Frequently Asked Questions

What is Contour Optik Inc's FDA import refusal history?

Contour Optik Inc (FEI: 3004744558) has 4 FDA import refusal record(s) in our database, spanning from 6/3/2014 to 10/1/2014.

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. Contour Optik Inc's FEI number is 3004744558.

What types of violations has Contour Optik Inc received?

Contour Optik 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 Contour Optik Inc come from?

All FDA import refusal data for Contour Optik 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.