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Coml Distr. Modolo Ltda.

⚠️ Moderate Risk

FEI: 3002680832 • Sao Paulo, Sao Paulo • BRAZIL

FEI

FEI Number

3002680832

📍

Location

Sao Paulo, Sao Paulo

🇧🇷

Country

BRAZIL
🏢

Address

Rua Manuel de Carvalho 414, , Sao Paulo, Sao Paulo, Brazil

Moderate Risk

FDA Import Risk Assessment

37.7
LowModerateHighCritical

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

Statistics

3
Total Refusals
3
Unique Violations
7/15/2002
Latest Refusal
7/11/2002
Earliest Refusal

Score Breakdown

Violation Severity
70.0×40%
Refusal Volume
22.3×30%
Recency
0.0×20%
Frequency
30.0×10%
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

111×

UNSAFE COL

The article appears to be, or to bear or contain a color additive which is unsafe within the meaning of Section 721(a).

2181×

LIST INGRE

The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(i)(2) of the FD&C Act in that it is fabricated from two or more ingredients and the label fails to bear the common or usual name of each such ingredient and/or the article purports to be a beverage containing vegetable or fruit juice, but does not bear a statement with appropriate prominence on the information panel of the total percentage of such fruit or vegetable juice contained in the food.

621×

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).

Refusal History

DateProductViolationsDivision
7/15/2002
30AFT04BEVERAGE BASE, MIXED FRUIT
218LIST INGRE
New England District Office (NWE-DO)
7/15/2002
30YCE02COCONUT MILK BEVERAGE BASE
62NEEDS FCE
New England District Office (NWE-DO)
7/11/2002
35AFE01GELATIN, FLAVORED
11UNSAFE COL
New England District Office (NWE-DO)

Frequently Asked Questions

What is Coml Distr. Modolo Ltda.'s FDA import refusal history?

Coml Distr. Modolo Ltda. (FEI: 3002680832) has 3 FDA import refusal record(s) in our database, spanning from 7/11/2002 to 7/15/2002.

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. Coml Distr. Modolo Ltda.'s FEI number is 3002680832.

What types of violations has Coml Distr. Modolo Ltda. received?

Coml Distr. Modolo Ltda. has been cited for 3 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 Coml Distr. Modolo Ltda. come from?

All FDA import refusal data for Coml Distr. Modolo Ltda. 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.