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Global TV Concepts, Ltd.

⚠️ Moderate Risk

FEI: 3001739169 • Coconut Creek, FL • UNITED STATES

FEI

FEI Number

3001739169

📍

Location

Coconut Creek, FL

🇺🇸
🏢

Address

6441 Lyons Rd, , Coconut Creek, FL, 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
12/20/2006
Latest Refusal
12/20/2006
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).

5081×

NO 510(K)

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.

Refusal History

DateProductViolationsDivision
12/20/2006
77MCKDEVICE, VOICE AMPLIFICATION
118NOT LISTED
508NO 510(K)
Chicago District Office (CHI-DO)

Frequently Asked Questions

What is Global TV Concepts, Ltd.'s FDA import refusal history?

Global TV Concepts, Ltd. (FEI: 3001739169) has 1 FDA import refusal record(s) in our database, spanning from 12/20/2006 to 12/20/2006.

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. Global TV Concepts, Ltd.'s FEI number is 3001739169.

What types of violations has Global TV Concepts, Ltd. received?

Global TV Concepts, Ltd. 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 Global TV Concepts, Ltd. come from?

All FDA import refusal data for Global TV Concepts, Ltd. 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.