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Neurocor

⚠️ Moderate Risk

FEI: 3004771993 • Servia, IN • UNITED STATES

FEI

FEI Number

3004771993

📍

Location

Servia, IN

🇺🇸
🏢

Address

Leonardo Da Vinci 4, , Servia, IN, 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
12/14/2004
Latest Refusal
12/14/2004
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

2371×

NO PMA

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the device appears to be a Class III device and does not appear to have in effect an approved application for premarket approval pursuant to Section 515 of the Act, or an exemption pursuant to Section 520(g)(1).

Refusal History

DateProductViolationsDivision
12/14/2004
74NKEPULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION
237NO PMA
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is Neurocor's FDA import refusal history?

Neurocor (FEI: 3004771993) has 1 FDA import refusal record(s) in our database, spanning from 12/14/2004 to 12/14/2004.

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. Neurocor's FEI number is 3004771993.

What types of violations has Neurocor received?

Neurocor 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 Neurocor come from?

All FDA import refusal data for Neurocor 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.