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CANDY AZTECA SA DE CV

⚠️ Moderate Risk

FEI: 3004070212 • Tepatitlan de Morelos, Jalisco • MEXICO

FEI

FEI Number

3004070212

📍

Location

Tepatitlan de Morelos, Jalisco

🇲🇽

Country

MEXICO
🏢

Address

Avenida Lopez Mateos 1327, Fracc. POPOTES, Tepatitlan de Morelos, Jalisco, Mexico

Moderate Risk

FDA Import Risk Assessment

37.9
LowModerateHighCritical

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

Statistics

13
Total Refusals
6
Unique Violations
5/9/2006
Latest Refusal
10/6/2003
Earliest Refusal

Score Breakdown

Violation Severity
50.4×40%
Refusal Volume
42.5×30%
Recency
0.0×20%
Frequency
50.2×10%
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

3249×

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)).

117×

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).

2745×

COLOR LBLG

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

4733×

LABELING

The article appears in violation of FPLA because of its placement, form and/or contents statement.

2601×

FALSE

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(a)(1 ) of the FD&C Act in that the labeling is false or misleading in any particular.

4821×

NUTRIT LBL

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded in that the label or labeling fails to bear the required nutrition information.

Refusal History

DateProductViolationsDivision
5/9/2006
33SGT06LOLLIPOP (WITHOUT CHOCOLATE)
11UNSAFE COL
274COLOR LBLG
324NO ENGLISH
473LABELING
Southwest Import District Office (SWI-DO)
5/9/2006
33SGT06LOLLIPOP (WITHOUT CHOCOLATE)
11UNSAFE COL
274COLOR LBLG
324NO ENGLISH
473LABELING
Southwest Import District Office (SWI-DO)
5/9/2006
33SGT06LOLLIPOP (WITHOUT CHOCOLATE)
11UNSAFE COL
274COLOR LBLG
324NO ENGLISH
473LABELING
Southwest Import District Office (SWI-DO)
4/18/2006
33SGT06LOLLIPOP (WITHOUT CHOCOLATE)
11UNSAFE COL
260FALSE
Southwest Import District Office (SWI-DO)
9/7/2005
33SGT06LOLLIPOP (WITHOUT CHOCOLATE)
11UNSAFE COL
274COLOR LBLG
Southwest Import District Office (SWI-DO)
9/7/2005
33SGT06LOLLIPOP (WITHOUT CHOCOLATE)
11UNSAFE COL
274COLOR LBLG
Southwest Import District Office (SWI-DO)
9/6/2005
33SGT06LOLLIPOP (WITHOUT CHOCOLATE)
324NO ENGLISH
Southwest Import District Office (SWI-DO)
8/16/2005
33SGT06LOLLIPOP (WITHOUT CHOCOLATE)
11UNSAFE COL
Southwest Import District Office (SWI-DO)
7/1/2005
33SGT06LOLLIPOP (WITHOUT CHOCOLATE)
324NO ENGLISH
Southwest Import District Office (SWI-DO)
4/5/2005
33SGT06LOLLIPOP (WITHOUT CHOCOLATE)
324NO ENGLISH
482NUTRIT LBL
Southwest Import District Office (SWI-DO)
12/9/2003
33SGT06LOLLIPOP (WITHOUT CHOCOLATE)
324NO ENGLISH
Southwest Import District Office (SWI-DO)
11/10/2003
33SGT06LOLLIPOP (WITHOUT CHOCOLATE)
324NO ENGLISH
Southwest Import District Office (SWI-DO)
10/6/2003
33SGT06LOLLIPOP (WITHOUT CHOCOLATE)
324NO ENGLISH
Southwest Import District Office (SWI-DO)

Frequently Asked Questions

What is CANDY AZTECA SA DE CV's FDA import refusal history?

CANDY AZTECA SA DE CV (FEI: 3004070212) has 13 FDA import refusal record(s) in our database, spanning from 10/6/2003 to 5/9/2006.

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. CANDY AZTECA SA DE CV's FEI number is 3004070212.

What types of violations has CANDY AZTECA SA DE CV received?

CANDY AZTECA SA DE CV has been cited for 6 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 CANDY AZTECA SA DE CV come from?

All FDA import refusal data for CANDY AZTECA SA DE CV 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.