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Dulce Innovaciones S.A. de C.V.

⚠️ High Risk

FEI: 3003604580 • Guadalajara, JAL • MEXICO

FEI

FEI Number

3003604580

📍

Location

Guadalajara, JAL

🇲🇽

Country

MEXICO
🏢

Address

Emiliano Zapata 30 672, Colonia El Mirador, Zona Olimpica, Guadalajara, JAL, Mexico

High Risk

FDA Import Risk Assessment

53.1
LowModerateHighCritical

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

Statistics

18
Total Refusals
4
Unique Violations
12/5/2006
Latest Refusal
10/22/2004
Earliest Refusal

Score Breakdown

Violation Severity
76.0×40%
Refusal Volume
47.4×30%
Recency
0.0×20%
Frequency
84.9×10%
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

1114×

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).

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.

2741×

COLOR LBLG

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

Refusal History

DateProductViolationsDivision
12/5/2006
33SGT06LOLLIPOP (WITHOUT CHOCOLATE)
11UNSAFE COL
Southwest Import District Office (SWI-DO)
8/7/2006
33LGT99SOFT CANDY WITHOUT NUTS AND FRUIT, N.E.C. (WITHOUT CHOCOLATE)
11UNSAFE COL
Southwest Import District Office (SWI-DO)
7/28/2006
33SGT06LOLLIPOP (WITHOUT CHOCOLATE)
11UNSAFE COL
Southwest Import District Office (SWI-DO)
6/16/2006
33SGT06LOLLIPOP (WITHOUT CHOCOLATE)
11UNSAFE COL
Southwest Import District Office (SWI-DO)
5/31/2006
33SGT06LOLLIPOP (WITHOUT CHOCOLATE)
11UNSAFE COL
Southwest Import District Office (SWI-DO)
5/22/2006
33SGT06LOLLIPOP (WITHOUT CHOCOLATE)
11UNSAFE COL
274COLOR LBLG
Southwest Import District Office (SWI-DO)
2/21/2006
33SGY99CANDY SPECIALTIES, N.E.C. (WITHOUT CHOCOLATE)
11UNSAFE COL
Southwest Import District Office (SWI-DO)
2/21/2006
33SGT06LOLLIPOP (WITHOUT CHOCOLATE)
11UNSAFE COL
Southwest Import District Office (SWI-DO)
2/21/2006
33SGY06LOLLIPOP (WITHOUT CHOCOLATE)
11UNSAFE COL
Southwest Import District Office (SWI-DO)
1/5/2006
33SGT06LOLLIPOP (WITHOUT CHOCOLATE)
11UNSAFE COL
Southwest Import District Office (SWI-DO)
11/8/2005
33SGT06LOLLIPOP (WITHOUT CHOCOLATE)
11UNSAFE COL
Southwest Import District Office (SWI-DO)
10/18/2005
33SGT06LOLLIPOP (WITHOUT CHOCOLATE)
324NO ENGLISH
Southwest Import District Office (SWI-DO)
10/18/2005
33SFT06LOLLIPOP (WITHOUT CHOCOLATE)
324NO ENGLISH
Southwest Import District Office (SWI-DO)
8/22/2005
33SHT99CANDY SPECIALTIES, N.E.C. (WITHOUT CHOCOLATE)
249FILTHY
Division of Southwest Imports (DSWI)
8/11/2005
33SGT06LOLLIPOP (WITHOUT CHOCOLATE)
11UNSAFE COL
Southwest Import District Office (SWI-DO)
7/1/2005
33LGT99SOFT CANDY WITHOUT NUTS AND FRUIT, N.E.C. (WITHOUT CHOCOLATE)
11UNSAFE COL
324NO ENGLISH
Southwest Import District Office (SWI-DO)
6/7/2005
33SGT99CANDY SPECIALTIES, N.E.C. (WITHOUT CHOCOLATE)
11UNSAFE COL
Southwest Import District Office (SWI-DO)
10/22/2004
33SGT06LOLLIPOP (WITHOUT CHOCOLATE)
324NO ENGLISH
Southwest Import District Office (SWI-DO)

Frequently Asked Questions

What is Dulce Innovaciones S.A. de C.V.'s FDA import refusal history?

Dulce Innovaciones S.A. de C.V. (FEI: 3003604580) has 18 FDA import refusal record(s) in our database, spanning from 10/22/2004 to 12/5/2006.

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. Dulce Innovaciones S.A. de C.V.'s FEI number is 3003604580.

What types of violations has Dulce Innovaciones S.A. de C.V. received?

Dulce Innovaciones 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 Dulce Innovaciones S.A. de C.V. come from?

All FDA import refusal data for Dulce Innovaciones 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.