ImportRefusal LogoImportRefusal

Neurosoft

⚠️ Moderate Risk

FEI: 3009025886 • Ivanovo, Ivanovskaya obl • RUSSIA

FEI

FEI Number

3009025886

📍

Location

Ivanovo, Ivanovskaya obl

🇷🇺

Country

RUSSIA
🏢

Address

ul. Voronina 5, , Ivanovo, Ivanovskaya obl, Russia

Moderate Risk

FDA Import Risk Assessment

27.8
LowModerateHighCritical

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

Statistics

4
Total Refusals
2
Unique Violations
10/5/2011
Latest Refusal
10/5/2011
Earliest Refusal

Score Breakdown

Violation Severity
40.0×40%
Refusal Volume
25.9×30%
Recency
0.0×20%
Frequency
40.0×10%
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

1184×

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).

3414×

REGISTERED

It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).

Refusal History

DateProductViolationsDivision
10/5/2011
89IKNELECTROMYOGRAPH, DIAGNOSTIC
118NOT LISTED
341REGISTERED
Florida District Office (FLA-DO)
10/5/2011
84GWQELECTROENCEPHALOGRAPH
118NOT LISTED
341REGISTERED
Florida District Office (FLA-DO)
10/5/2011
77EWOAUDIOMETER
118NOT LISTED
341REGISTERED
Florida District Office (FLA-DO)
10/5/2011
84OBPTRANSCRANIAL MAGNETIC STIMULATOR
118NOT LISTED
341REGISTERED
Florida District Office (FLA-DO)

Frequently Asked Questions

What is Neurosoft's FDA import refusal history?

Neurosoft (FEI: 3009025886) has 4 FDA import refusal record(s) in our database, spanning from 10/5/2011 to 10/5/2011.

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. Neurosoft's FEI number is 3009025886.

What types of violations has Neurosoft received?

Neurosoft has been cited for 2 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 Neurosoft come from?

All FDA import refusal data for Neurosoft 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.