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Aspen Pharma Trading Ltd.

⚠️ High Risk

FEI: 3012882574 • Dublin 24, Co. DUBLIN • IRELAND

FEI

FEI Number

3012882574

📍

Location

Dublin 24, Co. DUBLIN

🇮🇪

Country

IRELAND
🏢

Address

3010 Lake Drive, Citywest Business Campus, Dublin 24, Co. DUBLIN, Ireland

High Risk

FDA Import Risk Assessment

53.5
LowModerateHighCritical

This firm has a significant history of FDA import refusals with notable violations.

Statistics

2
Total Refusals
1
Unique Violations
10/8/2024
Latest Refusal
1/26/2017
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
Refusal Volume
17.7×30%
Recency
59.5×20%
Frequency
2.6×10%
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

752×

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
10/8/2024
62ICE30MERCAPTOPURINE (ANTI-NEOPLASTIC)
75UNAPPROVED
Division of Southeast Imports (DSEI)
1/26/2017
62IQB13CHLORAMBUCIL (ANTI-NEOPLASTIC)
75UNAPPROVED
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is Aspen Pharma Trading Ltd.'s FDA import refusal history?

Aspen Pharma Trading Ltd. (FEI: 3012882574) has 2 FDA import refusal record(s) in our database, spanning from 1/26/2017 to 10/8/2024.

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 Pharma Trading Ltd.'s FEI number is 3012882574.

What types of violations has Aspen Pharma Trading Ltd. received?

Aspen Pharma Trading Ltd. 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 Pharma Trading Ltd. come from?

All FDA import refusal data for Aspen Pharma Trading Ltd. 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.