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Helsinn Birex Pharmaceuticals Ltd.

⚠️ Moderate Risk

FEI: 3003724414 • Mulhuddart, Co. Dublin • IRELAND

FEI

FEI Number

3003724414

📍

Location

Mulhuddart, Co. Dublin

🇮🇪

Country

IRELAND
🏢

Address

Damastown Way, , Mulhuddart, Co. Dublin, Ireland

Moderate Risk

FDA Import Risk Assessment

33.6
LowModerateHighCritical

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

Statistics

3
Total Refusals
4
Unique Violations
1/30/2019
Latest Refusal
9/14/2007
Earliest Refusal

Score Breakdown

Violation Severity
66.7×40%
Refusal Volume
22.3×30%
Recency
0.0×20%
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

753×

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).

161×

DIRECTIONS

The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.

3331×

LACKS FIRM

The article is in package form and appears to not bear a label containing the name and place of business of the manufacturer, packer, or distributor.

3351×

LACKS N/C

The article is in package form and appears to not have a label containing an accurate statement of the quantity of the contents in terms of weight, measure or numerical count and no variations or exemptions have been prescribed by regs.

Refusal History

DateProductViolationsDivision
1/30/2019
66VAY99MISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
Division of Southeast Imports (DSEI)
6/7/2016
62GAY99ANTI-INFLAMMATORY N.E.C.
75UNAPPROVED
New Orleans District Office (NOL-DO)
9/14/2007
61TCP99ANTI-EMETIC/NAUSEANT N.E.C.
16DIRECTIONS
333LACKS FIRM
335LACKS N/C
75UNAPPROVED
Los Angeles District Office (LOS-DO)

Frequently Asked Questions

What is Helsinn Birex Pharmaceuticals Ltd.'s FDA import refusal history?

Helsinn Birex Pharmaceuticals Ltd. (FEI: 3003724414) has 3 FDA import refusal record(s) in our database, spanning from 9/14/2007 to 1/30/2019.

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. Helsinn Birex Pharmaceuticals Ltd.'s FEI number is 3003724414.

What types of violations has Helsinn Birex Pharmaceuticals Ltd. received?

Helsinn Birex Pharmaceuticals Ltd. has been cited for 4 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 Helsinn Birex Pharmaceuticals Ltd. come from?

All FDA import refusal data for Helsinn Birex Pharmaceuticals 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.