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Alexion Pharma International Operations Unlimited Co.

⚠️ High Risk

FEI: 3012889718 • Dublin 15, Co. DUBLIN • IRELAND

FEI

FEI Number

3012889718

📍

Location

Dublin 15, Co. DUBLIN

🇮🇪

Country

IRELAND
🏢

Address

College Business & Technology Park, Blanchardstown Road North, Dublin 15, Co. DUBLIN, Ireland

High Risk

FDA Import Risk Assessment

57.0
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
3/14/2025
Latest Refusal
3/14/2025
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
Refusal Volume
11.2×30%
Recency
83.2×20%
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
3/14/2025
66VCA99MISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is Alexion Pharma International Operations Unlimited Co.'s FDA import refusal history?

Alexion Pharma International Operations Unlimited Co. (FEI: 3012889718) has 1 FDA import refusal record(s) in our database, spanning from 3/14/2025 to 3/14/2025.

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. Alexion Pharma International Operations Unlimited Co.'s FEI number is 3012889718.

What types of violations has Alexion Pharma International Operations Unlimited Co. received?

Alexion Pharma International Operations Unlimited Co. 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 Alexion Pharma International Operations Unlimited Co. come from?

All FDA import refusal data for Alexion Pharma International Operations Unlimited Co. 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.