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European Directorate For The Quality Of Medicines

⚠️ Moderate Risk

FEI: 3006117303 • Strasbourg, Bas-Rhin • FRANCE

FEI

FEI Number

3006117303

📍

Location

Strasbourg, Bas-Rhin

🇫🇷

Country

FRANCE
🏢

Address

7 Allee Kastner, Cs 30026, Strasbourg, Bas-Rhin, France

Moderate Risk

FDA Import Risk Assessment

40.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
6/18/2012
Latest Refusal
6/18/2012
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
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

1861×

INSANITARY

The article is subject to refusal of admission pursuant to section 801(a)(3) in that the article appears to have been prepared, packed, or held under insanitary conditions whereby it may have been contaminated with filth, or whereby it may have been rendered injurious to health.

Refusal History

DateProductViolationsDivision
6/18/2012
88IAZHEPARIN
186INSANITARY
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is European Directorate For The Quality Of Medicines's FDA import refusal history?

European Directorate For The Quality Of Medicines (FEI: 3006117303) has 1 FDA import refusal record(s) in our database, spanning from 6/18/2012 to 6/18/2012.

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. European Directorate For The Quality Of Medicines's FEI number is 3006117303.

What types of violations has European Directorate For The Quality Of Medicines received?

European Directorate For The Quality Of Medicines 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 European Directorate For The Quality Of Medicines come from?

All FDA import refusal data for European Directorate For The Quality Of Medicines 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.