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Sorin Group Italia S.r.l.

✅ Low Risk

FEI: 3005687633 • Saluggia, Vercelli • ITALY

FEI

FEI Number

3005687633

📍

Location

Saluggia, Vercelli

🇮🇹

Country

ITALY
🏢

Address

Via Crescentino Sn, , Saluggia, Vercelli, Italy

Low Risk

FDA Import Risk Assessment

24.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
9/3/2014
Latest Refusal
9/3/2014
Earliest Refusal

Score Breakdown

Violation Severity
50.0×40%
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

4841×

DV NAME

The article appears to be a device and its labeling fails to bear the proprietary or established name.

Refusal History

DateProductViolationsDivision
9/3/2014
74DTDADAPTOR, LEAD, PACEMAKER
484DV NAME
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is Sorin Group Italia S.r.l.'s FDA import refusal history?

Sorin Group Italia S.r.l. (FEI: 3005687633) has 1 FDA import refusal record(s) in our database, spanning from 9/3/2014 to 9/3/2014.

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. Sorin Group Italia S.r.l.'s FEI number is 3005687633.

What types of violations has Sorin Group Italia S.r.l. received?

Sorin Group Italia S.r.l. 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 Sorin Group Italia S.r.l. come from?

All FDA import refusal data for Sorin Group Italia S.r.l. 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.