ImportRefusal LogoImportRefusal

Truelife Ltd.

⚠️ Moderate Risk

FEI: 3002420173 • Dublin • IRELAND

FEI

FEI Number

3002420173

📍

Location

Dublin

🇮🇪

Country

IRELAND
🏢

Address

Cookstown Industrial Estate, , Dublin, , Ireland

Moderate Risk

FDA Import Risk Assessment

29.7
LowModerateHighCritical

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

Statistics

3
Total Refusals
1
Unique Violations
4/29/2005
Latest Refusal
1/28/2005
Earliest Refusal

Score Breakdown

Violation Severity
50.0×40%
Refusal Volume
22.3×30%
Recency
0.0×20%
Frequency
30.0×10%
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

1183×

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
4/29/2005
89IOYSUPPORT, ARM
118NOT LISTED
Chicago District Office (CHI-DO)
1/28/2005
89IQKORTHOSIS, CERVICAL
118NOT LISTED
Chicago District Office (CHI-DO)
1/28/2005
89ITQJOINT, KNEE, EXTERNAL BRACE
118NOT LISTED
Chicago District Office (CHI-DO)

Frequently Asked Questions

What is Truelife Ltd.'s FDA import refusal history?

Truelife Ltd. (FEI: 3002420173) has 3 FDA import refusal record(s) in our database, spanning from 1/28/2005 to 4/29/2005.

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. Truelife Ltd.'s FEI number is 3002420173.

What types of violations has Truelife Ltd. received?

Truelife 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 Truelife Ltd. come from?

All FDA import refusal data for Truelife 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.