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Leurquin Laboratoires Mediobrun

⚠️ Moderate Risk

FEI: 3004526538 • Neuilly Sur Marne, Seine Saint Denis • FRANCE

FEI

FEI Number

3004526538

📍

Location

Neuilly Sur Marne, Seine Saint Denis

🇫🇷

Country

FRANCE
🏢

Address

1 Zone Industrielle des Chanoux, , Neuilly Sur Marne, Seine Saint Denis, France

Moderate Risk

FDA Import Risk Assessment

33.7
LowModerateHighCritical

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

Statistics

1
Total Refusals
3
Unique Violations
5/26/2004
Latest Refusal
5/26/2004
Earliest Refusal

Score Breakdown

Violation Severity
73.3×40%
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

1171×

DANGEROUS

The article appears to be dangerous to health when used in the dosage or manner, or with the frequency or duration, prescribed, recommended, or suggested in the labeling thereof.

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).

3311×

DR QUALITC

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the drug appears to be represented as not being recognized in an official compendium and appears its strength differs from or its quality or purity falls below, that which it purports or is represented to possess.

Refusal History

DateProductViolationsDivision
5/26/2004
60CBK46NAPHAZOLINE HCL (ADRENERGIC)
117DANGEROUS
118NOT LISTED
331DR QUALITC
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is Leurquin Laboratoires Mediobrun's FDA import refusal history?

Leurquin Laboratoires Mediobrun (FEI: 3004526538) has 1 FDA import refusal record(s) in our database, spanning from 5/26/2004 to 5/26/2004.

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. Leurquin Laboratoires Mediobrun's FEI number is 3004526538.

What types of violations has Leurquin Laboratoires Mediobrun received?

Leurquin Laboratoires Mediobrun has been cited for 3 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 Leurquin Laboratoires Mediobrun come from?

All FDA import refusal data for Leurquin Laboratoires Mediobrun 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.