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Elaboraciones Gasca

⚠️ Moderate Risk

FEI: 3003802335 • Mexico • MEXICO

FEI

FEI Number

3003802335

📍

Location

Mexico

🇲🇽

Country

MEXICO
🏢

Address

Calle 3 Lote 22 Mzacol Ampl Guadalupe, , Mexico, , Mexico

Moderate Risk

FDA Import Risk Assessment

31.3
LowModerateHighCritical

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

Statistics

5
Total Refusals
2
Unique Violations
2/28/2003
Latest Refusal
2/28/2003
Earliest Refusal

Score Breakdown

Violation Severity
44.0×40%
Refusal Volume
28.8×30%
Recency
0.0×20%
Frequency
50.0×10%
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

3244×

NO ENGLISH

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(f) of the FD&C Act in that any word, statement, or other information required by or under the authority of the FD&C Act to appear on the label or labeling is not prominently placed thereon with such conspicuousness (as compared with other words, statements, designs, or devices, in the labeling) and in such terms as to render it likely to be read and understood by the ordinary individual under customary terms of purchase and use (for example, label contains information in two or more languages but fails to repeat all required information in both languages in accordance with 21 CFR 101.15(c)(2), or label fails to include all required information in English in accordance with 21 CFR 101.15(c)(1), except in the case of articles distributed solely in the Commonwealth of Puerto Rico or in a Territory where the predominant language is one other than English)).

2491×

FILTHY

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the article appears to consist in whole or in part of a filthy, putrid, or decomposed substance or be otherwise unfit for food.

Refusal History

DateProductViolationsDivision
2/28/2003
33AGT01CARAMEL CANDY BAR, HARD, WITH NUTS OR NUT PRODUCTS (NOT COCONUT) (WITHOUT CHOCOLATE)
324NO ENGLISH
Atlanta District Office (ATL-DO)
2/28/2003
33LGT01CARAMEL CANDY BAR, SOFT, WITHOUT NUTS AND FRUIT (WITHOUT CHOCOLATE)
324NO ENGLISH
Atlanta District Office (ATL-DO)
2/28/2003
33BGT01CARAMEL CANDY BAR, HARD, WITH COCONUT (WITHOUT CHOCOLATE)
324NO ENGLISH
Atlanta District Office (ATL-DO)
2/28/2003
33HGT01CARAMEL CANDY BAR, SOFT WITH COCONUT (WITHOUT CHOCOLATE)
324NO ENGLISH
Atlanta District Office (ATL-DO)
2/28/2003
33EGY99HARD CANDY WITHOUT NUTS AND FRUIT, N.E.C. (WITHOUT CHOCOLATE)
249FILTHY
Atlanta District Office (ATL-DO)

Frequently Asked Questions

What is Elaboraciones Gasca's FDA import refusal history?

Elaboraciones Gasca (FEI: 3003802335) has 5 FDA import refusal record(s) in our database, spanning from 2/28/2003 to 2/28/2003.

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. Elaboraciones Gasca's FEI number is 3003802335.

What types of violations has Elaboraciones Gasca received?

Elaboraciones Gasca 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 Elaboraciones Gasca come from?

All FDA import refusal data for Elaboraciones Gasca 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.