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Azteca Confiteria S.A. de C.V.

⚠️ High Risk

FEI: 3019804449 • EL SALTO, Jalisco • MEXICO

FEI

FEI Number

3019804449

📍

Location

EL SALTO, Jalisco

🇲🇽

Country

MEXICO
🏢

Address

Carretera Guadalajara -El Salto KM 4 - Parque Industrial Panorma El Salto, Nave C, Col. Jardines de la Alameda, EL SALTO, Jalisco, Mexico

High Risk

FDA Import Risk Assessment

54.8
LowModerateHighCritical

This firm has a significant history of FDA import refusals with notable violations.

Statistics

5
Total Refusals
4
Unique Violations
4/22/2025
Latest Refusal
11/29/2023
Earliest Refusal

Score Breakdown

Violation Severity
63.8×40%
Refusal Volume
28.8×30%
Recency
85.6×20%
Frequency
35.8×10%
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

2743×

COLOR LBLG

The article appears to contain an artificial coloring and it fails to bear labeling stating that fact.

112×

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).

1572×

FOREIGN OB

The article appears to consist in whole or in part of a filthy, putrid, or decomposed substance, or is otherwise unfit for food in that it appears to contain foreign objects.

3241×

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)).

Refusal History

DateProductViolationsDivision
4/22/2025
33MGB07GEL CANDY ON A STICK CANDY
11UNSAFE COL
274COLOR LBLG
Division of Southwest Imports (DSWI)
11/8/2024
33MGB07GEL CANDY ON A STICK CANDY
11UNSAFE COL
274COLOR LBLG
Division of Southwest Imports (DSWI)
12/1/2023
33MGB07GEL CANDY ON A STICK CANDY
274COLOR LBLG
324NO ENGLISH
Division of Southwest Imports (DSWI)
12/1/2023
33MGB07GEL CANDY ON A STICK CANDY
157FOREIGN OB
Division of Southwest Imports (DSWI)
11/29/2023
33MHT05GEL CUPS CANDY
157FOREIGN OB
Division of Southwest Imports (DSWI)

Frequently Asked Questions

What is Azteca Confiteria S.A. de C.V.'s FDA import refusal history?

Azteca Confiteria S.A. de C.V. (FEI: 3019804449) has 5 FDA import refusal record(s) in our database, spanning from 11/29/2023 to 4/22/2025.

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. Azteca Confiteria S.A. de C.V.'s FEI number is 3019804449.

What types of violations has Azteca Confiteria S.A. de C.V. received?

Azteca Confiteria S.A. de C.V. has been cited for 4 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 Azteca Confiteria S.A. de C.V. come from?

All FDA import refusal data for Azteca Confiteria S.A. de C.V. 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.