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Survivalink Corporation

⚠️ Moderate Risk

FEI: 1000423710 • Hopkins, MN • UNITED STATES

FEI

FEI Number

1000423710

📍

Location

Hopkins, MN

🇺🇸
🏢

Address

5420 Feltl Rd, , Hopkins, MN, United States

Moderate Risk

FDA Import Risk Assessment

36.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
3/31/2003
Latest Refusal
3/31/2003
Earliest Refusal

Score Breakdown

Violation Severity
80.0×40%
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

1261×

FAILS STD

The article appears to be a device which is subject to a performance standard established under Section 514 and does not appear to be in all respects in conformity with such standard.

Refusal History

DateProductViolationsDivision
3/31/2003
74LDDDC-DEFIBRILLATOR, LOW-ENERGY, (INCLUDING PADDLES)
126FAILS STD
Chicago District Office (CHI-DO)

Frequently Asked Questions

What is Survivalink Corporation's FDA import refusal history?

Survivalink Corporation (FEI: 1000423710) has 1 FDA import refusal record(s) in our database, spanning from 3/31/2003 to 3/31/2003.

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. Survivalink Corporation's FEI number is 1000423710.

What types of violations has Survivalink Corporation received?

Survivalink Corporation 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 Survivalink Corporation come from?

All FDA import refusal data for Survivalink Corporation 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.