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HERBALGEM

⚠️ Moderate Risk

FEI: 3011395527 • Vielsalm, Luxemburg • BELGIUM

FEI

FEI Number

3011395527

📍

Location

Vielsalm, Luxemburg

🇧🇪

Country

BELGIUM
🏢

Address

Place des Chasseurs Ardennais, , Vielsalm, Luxemburg, Belgium

Moderate Risk

FDA Import Risk Assessment

28.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
4/10/2015
Latest Refusal
4/10/2015
Earliest Refusal

Score Breakdown

Violation Severity
60.0×40%
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

2231×

FALSE

The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose labeling appears to be false or misleading.

Refusal History

DateProductViolationsDivision
4/10/2015
86LPNACCESSORIES TO CONTACT LENSES - CLEANING AND WETTING AGENTS
223FALSE
Division of Northeast Imports (DNEI)

Frequently Asked Questions

What is HERBALGEM's FDA import refusal history?

HERBALGEM (FEI: 3011395527) has 1 FDA import refusal record(s) in our database, spanning from 4/10/2015 to 4/10/2015.

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. HERBALGEM's FEI number is 3011395527.

What types of violations has HERBALGEM received?

HERBALGEM 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 HERBALGEM come from?

All FDA import refusal data for HERBALGEM 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.