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Visiplex Communications

⚠️ Moderate Risk

FEI: 3004113219 • Deerfield, IL • UNITED STATES

FEI

FEI Number

3004113219

📍

Location

Deerfield, IL

🇺🇸
🏢

Address

1141 Lake Cook Rd Ste G, , Deerfield, IL, United States

Moderate Risk

FDA Import Risk Assessment

28.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
2
Unique Violations
6/18/2002
Latest Refusal
6/18/2002
Earliest Refusal

Score Breakdown

Violation Severity
60.0×40%
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).

471×

NON STD

The article is subject to refusal of admission pursuant to section 536(a) of the Federal Food, Drug, and Cosmetic Act (FFDCA) in that it appears to be an electronic product offered for importation into the United States which fails to comply with an applicable standard prescribed pursuant to section 534 of the FFDCA.

Refusal History

DateProductViolationsDivision
6/18/2002
90IZISYSTEM, X-RAY, ANGIOGRAPHIC
118NOT LISTED
47NON STD
Chicago District Office (CHI-DO)

Frequently Asked Questions

What is Visiplex Communications's FDA import refusal history?

Visiplex Communications (FEI: 3004113219) has 1 FDA import refusal record(s) in our database, spanning from 6/18/2002 to 6/18/2002.

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. Visiplex Communications's FEI number is 3004113219.

What types of violations has Visiplex Communications received?

Visiplex Communications 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 Visiplex Communications come from?

All FDA import refusal data for Visiplex Communications 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.