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Hollister Ulc

⚠️ Moderate Risk

FEI: 3005028195 • Ballina, Co. MAYO • IRELAND

FEI

FEI Number

3005028195

📍

Location

Ballina, Co. MAYO

🇮🇪

Country

IRELAND
🏢

Address

Foxford Road, REHINS, Ballina, Co. MAYO, Ireland

Moderate Risk

FDA Import Risk Assessment

31.8
LowModerateHighCritical

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

Statistics

4
Total Refusals
1
Unique Violations
4/30/2013
Latest Refusal
4/30/2013
Earliest Refusal

Score Breakdown

Violation Severity
50.0×40%
Refusal Volume
25.9×30%
Recency
0.0×20%
Frequency
40.0×10%
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

1184×

NOT LISTED

It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).

Refusal History

DateProductViolationsDivision
4/30/2013
78FONBAG, DRAINAGE, WITH ADHESIVE, OSTOMY
118NOT LISTED
Division of Northeast Imports (DNEI)
4/30/2013
78FONBAG, DRAINAGE, WITH ADHESIVE, OSTOMY
118NOT LISTED
Division of Northeast Imports (DNEI)
4/30/2013
78KNTTUBES, GASTROINTESTINAL (AND ACCESSORIES)
118NOT LISTED
Division of Northeast Imports (DNEI)
4/30/2013
78FONBAG, DRAINAGE, WITH ADHESIVE, OSTOMY
118NOT LISTED
Division of Northeast Imports (DNEI)

Frequently Asked Questions

What is Hollister Ulc's FDA import refusal history?

Hollister Ulc (FEI: 3005028195) has 4 FDA import refusal record(s) in our database, spanning from 4/30/2013 to 4/30/2013.

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. Hollister Ulc's FEI number is 3005028195.

What types of violations has Hollister Ulc received?

Hollister Ulc 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 Hollister Ulc come from?

All FDA import refusal data for Hollister Ulc 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.