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Sunshades Eyewear

✅ Low Risk

FEI: 3006186143 • Alexandria, New South Wales • AUSTRALIA

FEI

FEI Number

3006186143

📍

Location

Alexandria, New South Wales

🇦🇺

Country

AUSTRALIA
🏢

Address

110 McEvoy St, , Alexandria, New South Wales, Australia

Low Risk

FDA Import Risk Assessment

22.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
2
Unique Violations
10/16/2015
Latest Refusal
10/16/2015
Earliest Refusal

Score Breakdown

Violation Severity
45.0×40%
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

2311×

LENS CERT

The lenses are declared by accompanying certificate to meet the requirements for impact-resistant lenses in 21 CFR 801.410 but does not appear to be impact-resistant.

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
10/16/2015
86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)
231LENS CERT
341REGISTERED
Los Angeles District Office (LOS-DO)

Frequently Asked Questions

What is Sunshades Eyewear's FDA import refusal history?

Sunshades Eyewear (FEI: 3006186143) has 1 FDA import refusal record(s) in our database, spanning from 10/16/2015 to 10/16/2015.

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. Sunshades Eyewear's FEI number is 3006186143.

What types of violations has Sunshades Eyewear received?

Sunshades Eyewear 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 Sunshades Eyewear come from?

All FDA import refusal data for Sunshades Eyewear 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.