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Comercial E Distribuidora Duere Ltd

⚠️ Moderate Risk

FEI: 3003219069 • Hortolandia • BRAZIL

FEI

FEI Number

3003219069

📍

Location

Hortolandia

🇧🇷

Country

BRAZIL
🏢

Address

Estrada 7, , Hortolandia, , Brazil

Moderate Risk

FDA Import Risk Assessment

39.3
LowModerateHighCritical

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

Statistics

2
Total Refusals
2
Unique Violations
4/26/2002
Latest Refusal
4/26/2002
Earliest Refusal

Score Breakdown

Violation Severity
80.0×40%
Refusal Volume
17.7×30%
Recency
0.0×20%
Frequency
20.0×10%
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

622×

NEEDS FCE

It appears the manufacturer is not registered as a low acid canned food or acidified food manufacturer pursuant to 21 CFR 108.25(c)(1) or 108.35(c)(1).

832×

NO PROCESS

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the manufacturer's failure to file a scheduled process demonstrates that the product is not being manufactured under the mandatory provisions of 21 CFR Part 108 and therefore appears to have been manufactured, processed, or packed, under insanitary conditions whereby it may have been rendered injurious to health.

Refusal History

DateProductViolationsDivision
4/26/2002
30BCT06BEVERAGE BASE, SUBTROPICAL OR TROPICAL FRUIT, LIQUID
62NEEDS FCE
83NO PROCESS
New York District Office (NYK-DO)
4/26/2002
24TET39HEART OF PALM (LEAF & STEM VEGETABLE)
62NEEDS FCE
83NO PROCESS
New York District Office (NYK-DO)

Frequently Asked Questions

What is Comercial E Distribuidora Duere Ltd's FDA import refusal history?

Comercial E Distribuidora Duere Ltd (FEI: 3003219069) has 2 FDA import refusal record(s) in our database, spanning from 4/26/2002 to 4/26/2002.

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. Comercial E Distribuidora Duere Ltd's FEI number is 3003219069.

What types of violations has Comercial E Distribuidora Duere Ltd received?

Comercial E Distribuidora Duere 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 Comercial E Distribuidora Duere Ltd come from?

All FDA import refusal data for Comercial E Distribuidora Duere 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.