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CoolSystems, Inc. DBA Game Ready

⚠️ Moderate Risk

FEI: 3003186150 • Alpharetta, GA • UNITED STATES

FEI

FEI Number

3003186150

📍

Location

Alpharetta, GA

🇺🇸
🏢

Address

5405 Windward Pkwy, , Alpharetta, GA, United States

Moderate Risk

FDA Import Risk Assessment

26.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
2
Unique Violations
11/6/2009
Latest Refusal
11/6/2009
Earliest Refusal

Score Breakdown

Violation Severity
55.0×40%
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).

4761×

NO REGISTR

The article appears to be an electronic product that does not comply with an applicable standard as prescribed by Section 534 because no reporting has been provided as required by Section 537(b).

Refusal History

DateProductViolationsDivision
11/6/2009
80LDQDEVICE, GENERAL MEDICAL
118NOT LISTED
476NO REGISTR
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is CoolSystems, Inc. DBA Game Ready's FDA import refusal history?

CoolSystems, Inc. DBA Game Ready (FEI: 3003186150) has 1 FDA import refusal record(s) in our database, spanning from 11/6/2009 to 11/6/2009.

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. CoolSystems, Inc. DBA Game Ready's FEI number is 3003186150.

What types of violations has CoolSystems, Inc. DBA Game Ready received?

CoolSystems, Inc. DBA Game Ready 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 CoolSystems, Inc. DBA Game Ready come from?

All FDA import refusal data for CoolSystems, Inc. DBA Game Ready 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.