ImportRefusal LogoImportRefusal

Denbur Inc

⚠️ Moderate Risk

FEI: 3006264569 • Westmont, IL • UNITED STATES

FEI

FEI Number

3006264569

📍

Location

Westmont, IL

🇺🇸
🏢

Address

650 Blackhawk Dr, , Westmont, IL, United States

Moderate Risk

FDA Import Risk Assessment

32.7
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
2/18/2025
Latest Refusal
2/18/2025
Earliest Refusal

Score Breakdown

Violation Severity
30.0×40%
Refusal Volume
11.2×30%
Recency
81.8×20%
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

3411×

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
2/18/2025
80FRLFIBER, MEDICAL, ABSORBENT
341REGISTERED
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is Denbur Inc's FDA import refusal history?

Denbur Inc (FEI: 3006264569) has 1 FDA import refusal record(s) in our database, spanning from 2/18/2025 to 2/18/2025.

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. Denbur Inc's FEI number is 3006264569.

What types of violations has Denbur Inc received?

Denbur 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 Denbur Inc come from?

All FDA import refusal data for Denbur 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.