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FABRICA DE DULCES FRADI, S.A. DE C.V.

⚠️ Moderate Risk

FEI: 3004300845 • Guadalajara, Jalisco • MEXICO

FEI

FEI Number

3004300845

📍

Location

Guadalajara, Jalisco

🇲🇽

Country

MEXICO
🏢

Address

Avenida De Los Maestros 1629-A, Col. Mezquitan Country, Guadalajara, Guadalajara, Jalisco, Mexico

Moderate Risk

FDA Import Risk Assessment

32.4
LowModerateHighCritical

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

Statistics

10
Total Refusals
5
Unique Violations
5/10/2013
Latest Refusal
4/10/2007
Earliest Refusal

Score Breakdown

Violation Severity
48.0×40%
Refusal Volume
38.6×30%
Recency
0.0×20%
Frequency
16.4×10%
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

3287×

USUAL NAME

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(i)(1) of the FD&C Act in that the label fails to bear the common or usual name of the food, if any there be.

113×

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).

2742×

COLOR LBLG

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

3242×

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)).

2561×

INCONSPICU

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
5/10/2013
33SGT06LOLLIPOP (WITHOUT CHOCOLATE)
11UNSAFE COL
274COLOR LBLG
Southwest Import District Office (SWI-DO)
4/10/2013
33SGT06LOLLIPOP (WITHOUT CHOCOLATE)
11UNSAFE COL
274COLOR LBLG
Southwest Import District Office (SWI-DO)
3/14/2013
33LGT14TAFFY (TOFFEE), KISSES CANDY, SOFT, WITHOUT NUTS AND FRUIT (WITHOUT CHOCOLATE)
256INCONSPICU
324NO ENGLISH
328USUAL NAME
Southwest Import District Office (SWI-DO)
7/9/2009
33LYY02CARAMEL CANDY PIECES, SOFT, WITHOUT NUTS AND FRUIT (WITHOUT CHOCOLATE)
328USUAL NAME
Southwest Import District Office (SWI-DO)
7/9/2009
33LYY02CARAMEL CANDY PIECES, SOFT, WITHOUT NUTS AND FRUIT (WITHOUT CHOCOLATE)
328USUAL NAME
Southwest Import District Office (SWI-DO)
7/9/2009
33LYY02CARAMEL CANDY PIECES, SOFT, WITHOUT NUTS AND FRUIT (WITHOUT CHOCOLATE)
328USUAL NAME
Southwest Import District Office (SWI-DO)
7/9/2009
33LYY02CARAMEL CANDY PIECES, SOFT, WITHOUT NUTS AND FRUIT (WITHOUT CHOCOLATE)
328USUAL NAME
Southwest Import District Office (SWI-DO)
7/9/2009
33LYY02CARAMEL CANDY PIECES, SOFT, WITHOUT NUTS AND FRUIT (WITHOUT CHOCOLATE)
328USUAL NAME
Southwest Import District Office (SWI-DO)
7/9/2009
33LYY02CARAMEL CANDY PIECES, SOFT, WITHOUT NUTS AND FRUIT (WITHOUT CHOCOLATE)
328USUAL NAME
Southwest Import District Office (SWI-DO)
4/10/2007
33LGT05CANDY BAR OR PIECES (NOT CARAMEL OR FONDANT), SOFT, WITHOUT NUTS AND FRUIT (WITHOUT CHOCOLATE)
11UNSAFE COL
324NO ENGLISH
Southwest Import District Office (SWI-DO)

Frequently Asked Questions

What is FABRICA DE DULCES FRADI, S.A. DE C.V.'s FDA import refusal history?

FABRICA DE DULCES FRADI, S.A. DE C.V. (FEI: 3004300845) has 10 FDA import refusal record(s) in our database, spanning from 4/10/2007 to 5/10/2013.

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. FABRICA DE DULCES FRADI, S.A. DE C.V.'s FEI number is 3004300845.

What types of violations has FABRICA DE DULCES FRADI, S.A. DE C.V. received?

FABRICA DE DULCES FRADI, S.A. DE C.V. has been cited for 5 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 FABRICA DE DULCES FRADI, S.A. DE C.V. come from?

All FDA import refusal data for FABRICA DE DULCES FRADI, 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.