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Aspen Notre Dame de Bondeville

⚠️ Moderate Risk

FEI: 3002808079 • Notre Dame de Bondeville, Seine Maritime • FRANCE

FEI

FEI Number

3002808079

📍

Location

Notre Dame de Bondeville, Seine Maritime

🇫🇷

Country

FRANCE
🏢

Address

1 rue de l Abbaye, , Notre Dame de Bondeville, Seine Maritime, 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
3/5/2015
Latest Refusal
3/5/2015
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

751×

UNAPPROVED

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA).

Refusal History

DateProductViolationsDivision
3/5/2015
65ICP02FONDAPARINUX SODIUM
75UNAPPROVED
Atlanta District Office (ATL-DO)

Frequently Asked Questions

What is Aspen Notre Dame de Bondeville's FDA import refusal history?

Aspen Notre Dame de Bondeville (FEI: 3002808079) has 1 FDA import refusal record(s) in our database, spanning from 3/5/2015 to 3/5/2015.

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. Aspen Notre Dame de Bondeville's FEI number is 3002808079.

What types of violations has Aspen Notre Dame de Bondeville received?

Aspen Notre Dame de Bondeville 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 Aspen Notre Dame de Bondeville come from?

All FDA import refusal data for Aspen Notre Dame de Bondeville 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.