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Kobayashi Consumer Products LLC dba Heatmax Inc

⚠️ Moderate Risk

FEI: 1000112007 • Dalton, GA • UNITED STATES

FEI

FEI Number

1000112007

📍

Location

Dalton, GA

🇺🇸
🏢

Address

245 Kraft Dr, , Dalton, GA, United States

Moderate Risk

FDA Import Risk Assessment

32.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
10/5/2011
Latest Refusal
10/5/2011
Earliest Refusal

Score Breakdown

Violation Severity
70.0×40%
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

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
10/5/2011
89MLXPAD, MEDICATED, ADHESIVE, NON-ELECTRIC
508NO 510(K)
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is Kobayashi Consumer Products LLC dba Heatmax Inc's FDA import refusal history?

Kobayashi Consumer Products LLC dba Heatmax Inc (FEI: 1000112007) has 1 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. Kobayashi Consumer Products LLC dba Heatmax Inc's FEI number is 1000112007.

What types of violations has Kobayashi Consumer Products LLC dba Heatmax Inc received?

Kobayashi Consumer Products LLC dba Heatmax Inc 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 Kobayashi Consumer Products LLC dba Heatmax Inc come from?

All FDA import refusal data for Kobayashi Consumer Products LLC dba Heatmax Inc 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.