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St Jude Cardiology Division Incorporated

✅ Low Risk

FEI: 3012179728 • Saint Paul, MN • UNITED STATES

FEI

FEI Number

3012179728

📍

Location

Saint Paul, MN

🇺🇸
🏢

Address

2305 Walnut St N, , Saint Paul, MN, United States

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
1/29/2016
Latest Refusal
1/29/2016
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

1181×

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
1/29/2016
80KZHINTRODUCER, SYRINGE NEEDLE
118NOT LISTED
New York District Office (NYK-DO)

Frequently Asked Questions

What is St Jude Cardiology Division Incorporated's FDA import refusal history?

St Jude Cardiology Division Incorporated (FEI: 3012179728) has 1 FDA import refusal record(s) in our database, spanning from 1/29/2016 to 1/29/2016.

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. St Jude Cardiology Division Incorporated's FEI number is 3012179728.

What types of violations has St Jude Cardiology Division Incorporated received?

St Jude Cardiology Division Incorporated 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 St Jude Cardiology Division Incorporated come from?

All FDA import refusal data for St Jude Cardiology Division Incorporated 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.