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SPECIAL EYES

⚠️ Moderate Risk

FEI: 3014005825 • Lons Le Saunier, Jura • FRANCE

FEI

FEI Number

3014005825

📍

Location

Lons Le Saunier, Jura

🇫🇷

Country

FRANCE
🏢

Address

174 Rue Du Docteur Jean Michel, , Lons Le Saunier, Jura, France

Moderate Risk

FDA Import Risk Assessment

31.3
LowModerateHighCritical

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

Statistics

2
Total Refusals
2
Unique Violations
9/30/2018
Latest Refusal
9/30/2018
Earliest Refusal

Score Breakdown

Violation Severity
60.0×40%
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

1181×

NOT LISTED

It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).

471×

NON STD

The article is subject to refusal of admission pursuant to section 536(a) of the Federal Food, Drug, and Cosmetic Act (FFDCA) in that it appears to be an electronic product offered for importation into the United States which fails to comply with an applicable standard prescribed pursuant to section 534 of the FFDCA.

Refusal History

DateProductViolationsDivision
9/30/2018
86HQZFRAME, SPECTACLE
118NOT LISTED
Division of Southeast Imports (DSEI)
9/30/2018
95RESLASER POINTER, SURVEYING, LEVELING, ALIGNMENT LASER PRODUCTS
47NON STD
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is SPECIAL EYES's FDA import refusal history?

SPECIAL EYES (FEI: 3014005825) has 2 FDA import refusal record(s) in our database, spanning from 9/30/2018 to 9/30/2018.

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. SPECIAL EYES's FEI number is 3014005825.

What types of violations has SPECIAL EYES received?

SPECIAL EYES 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 SPECIAL EYES come from?

All FDA import refusal data for SPECIAL EYES 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.