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Fournier Laboratories Ireland, Ltd. (Abbvie Cork)

Low Risk

FEI: 3004134577 • Carrigtwohill, Co. CORK • IRELAND

FEI

FEI Number

3004134577

📍

Location

Carrigtwohill, Co. CORK

🇮🇪

Country

IRELAND
🏢

Address

Ida Industrial Estate, Anngrove, Carrigtwohill, Co. CORK, Ireland

Low Risk

FDA Import Risk Assessment

20.3
LowModerateHighCritical

This firm has a minimal history of FDA import refusals with low-severity violations.

Statistics

1
Total Refusals
1
Unique Violations
7/3/2018
Latest Refusal
7/3/2018
Earliest Refusal

Score Breakdown

Violation Severity
40.0×40%
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

3361×

INCONSPICU

Information required by the Act to be on the label or labeling does not appear to be conspicuous enough as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use.

Refusal History

DateProductViolationsDivision
7/3/2018
64EIY03PANCRELIPASE (ENZYME)
336INCONSPICU
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is Fournier Laboratories Ireland, Ltd. (Abbvie Cork)'s FDA import refusal history?

Fournier Laboratories Ireland, Ltd. (Abbvie Cork) (FEI: 3004134577) has 1 FDA import refusal record(s) in our database, spanning from 7/3/2018 to 7/3/2018.

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. Fournier Laboratories Ireland, Ltd. (Abbvie Cork)'s FEI number is 3004134577.

What types of violations has Fournier Laboratories Ireland, Ltd. (Abbvie Cork) received?

Fournier Laboratories Ireland, Ltd. (Abbvie Cork) 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 Fournier Laboratories Ireland, Ltd. (Abbvie Cork) come from?

All FDA import refusal data for Fournier Laboratories Ireland, Ltd. (Abbvie Cork) 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.