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Reserva de Minas Industria e Comercio Ltda.

⚠️ Moderate Risk

FEI: 3010594196 • Machado, Minas Gerais • BRAZIL

FEI

FEI Number

3010594196

📍

Location

Machado, Minas Gerais

🇧🇷

Country

BRAZIL
🏢

Address

Rodovia BR 267 Km 445, , Machado, Minas Gerais, 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

1
Total Refusals
3
Unique Violations
6/26/2015
Latest Refusal
6/26/2015
Earliest Refusal

Score Breakdown

Violation Severity
83.3×40%
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

33001×

ALLERGEN

the label fails to declare all major food allergens present in the product, as required by section 403(w)(1).

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).

831×

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
6/26/2015
33TCT02CARAMEL TOPPING (TOPPING WITHOUT FRUIT, NUTS OR CHOCOLATE)
3300ALLERGEN
62NEEDS FCE
83NO PROCESS
New York District Office (NYK-DO)

Frequently Asked Questions

What is Reserva de Minas Industria e Comercio Ltda.'s FDA import refusal history?

Reserva de Minas Industria e Comercio Ltda. (FEI: 3010594196) has 1 FDA import refusal record(s) in our database, spanning from 6/26/2015 to 6/26/2015.

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. Reserva de Minas Industria e Comercio Ltda.'s FEI number is 3010594196.

What types of violations has Reserva de Minas Industria e Comercio Ltda. received?

Reserva de Minas Industria e Comercio 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 Reserva de Minas Industria e Comercio Ltda. come from?

All FDA import refusal data for Reserva de Minas Industria e Comercio 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.