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Gourmet Home Made Ltda

⚠️ Moderate Risk

FEI: 3005114072 • Yumbo Valle • COLOMBIA

FEI

FEI Number

3005114072

📍

Location

Yumbo Valle

🇨🇴

Country

COLOMBIA
🏢

Address

Cr 31 No. 10-173, , Yumbo Valle, , Colombia

Moderate Risk

FDA Import Risk Assessment

43.8
LowModerateHighCritical

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

Statistics

4
Total Refusals
2
Unique Violations
6/16/2005
Latest Refusal
6/16/2005
Earliest Refusal

Score Breakdown

Violation Severity
80.0×40%
Refusal Volume
25.9×30%
Recency
0.0×20%
Frequency
40.0×10%
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

624×

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).

834×

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
6/16/2005
24KCB11CHINESE EGGPLANT,THAI EGGPLANT, WITH SAUCE
62NEEDS FCE
83NO PROCESS
Florida District Office (FLA-DO)
6/16/2005
24TCB99LEAF & STEM VEGETABLES, N.E.C.
62NEEDS FCE
83NO PROCESS
Florida District Office (FLA-DO)
6/16/2005
25SCB01MUSHROOM, COMMON (AGARICUS BISPORUS), FUNGI PRODUCTS, N.E.C.
62NEEDS FCE
83NO PROCESS
Florida District Office (FLA-DO)
6/16/2005
16CCB45TUNA (ALBACORE, YELLOWFIN, BLUEFIN, SKIPJACK, ETC.), CAKES, BALLS, ETC.
62NEEDS FCE
83NO PROCESS
Florida District Office (FLA-DO)

Frequently Asked Questions

What is Gourmet Home Made Ltda's FDA import refusal history?

Gourmet Home Made Ltda (FEI: 3005114072) has 4 FDA import refusal record(s) in our database, spanning from 6/16/2005 to 6/16/2005.

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. Gourmet Home Made Ltda's FEI number is 3005114072.

What types of violations has Gourmet Home Made Ltda received?

Gourmet Home Made Ltda 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 Gourmet Home Made Ltda come from?

All FDA import refusal data for Gourmet Home Made 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.