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DULCES GABY SA DE CV

⚠️ Moderate Risk

FEI: 3009856970 • Mexico City, Distrito Federal • MEXICO

FEI

FEI Number

3009856970

📍

Location

Mexico City, Distrito Federal

🇲🇽

Country

MEXICO
🏢

Address

Avenida Miguel Othon De Mendizabal, Gustavo A. Madero; Col. Nuev,, Mexico City, Distrito Federal, Mexico

Moderate Risk

FDA Import Risk Assessment

31.9
LowModerateHighCritical

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

Statistics

7
Total Refusals
8
Unique Violations
7/17/2014
Latest Refusal
12/1/2003
Earliest Refusal

Score Breakdown

Violation Severity
53.1×40%
Refusal Volume
33.5×30%
Recency
0.0×20%
Frequency
6.6×10%
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

4824×

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.

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).

2741×

COLOR LBLG

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

2801×

UNSAFE SUB

The article appears to bear or contain a substance which is unsafe within the meaning of Section 406.

3201×

LACKS FIRM

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(e)(1) of the FD&C Act in that the food is in package form and the label fails to bear the name and place of business of the manufacturer, packer, or distributor.

3211×

LACKS N/C

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(e)(2) of the FD&C Act in that the food is in package form and the label fails to bear an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count in accordance with Section 403(e)(2) of the FD&C Act.

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)).

2181×

LIST INGRE

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)(2) of the FD&C Act in that it is fabricated from two or more ingredients and the label fails to bear the common or usual name of each such ingredient and/or the article purports to be a beverage containing vegetable or fruit juice, but does not bear a statement with appropriate prominence on the information panel of the total percentage of such fruit or vegetable juice contained in the food.

Refusal History

DateProductViolationsDivision
7/17/2014
33LGY02CARAMEL CANDY PIECES, SOFT, WITHOUT NUTS AND FRUIT (WITHOUT CHOCOLATE)
11UNSAFE COL
Southwest Import District Office (SWI-DO)
7/17/2014
33LGY02CARAMEL CANDY PIECES, SOFT, WITHOUT NUTS AND FRUIT (WITHOUT CHOCOLATE)
11UNSAFE COL
Southwest Import District Office (SWI-DO)
7/23/2013
33LGY02CARAMEL CANDY PIECES, SOFT, WITHOUT NUTS AND FRUIT (WITHOUT CHOCOLATE)
11UNSAFE COL
218LIST INGRE
274COLOR LBLG
280UNSAFE SUB
Southwest Import District Office (SWI-DO)
5/17/2005
33SGT06LOLLIPOP (WITHOUT CHOCOLATE)
482NUTRIT LBL
Southwest Import District Office (SWI-DO)
5/17/2005
33SGT06LOLLIPOP (WITHOUT CHOCOLATE)
482NUTRIT LBL
Southwest Import District Office (SWI-DO)
5/17/2005
34FGT99CHOCOLATE AND CHOCOLATE COVERED CANDY, WITHOUT NUTS AND FRUIT, N.E.C.
320LACKS FIRM
321LACKS N/C
482NUTRIT LBL
Southwest Import District Office (SWI-DO)
12/1/2003
33SGT99CANDY SPECIALTIES, N.E.C. (WITHOUT CHOCOLATE)
324NO ENGLISH
482NUTRIT LBL
Southwest Import District Office (SWI-DO)

Frequently Asked Questions

What is DULCES GABY SA DE CV's FDA import refusal history?

DULCES GABY SA DE CV (FEI: 3009856970) has 7 FDA import refusal record(s) in our database, spanning from 12/1/2003 to 7/17/2014.

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. DULCES GABY SA DE CV's FEI number is 3009856970.

What types of violations has DULCES GABY SA DE CV received?

DULCES GABY SA DE CV has been cited for 8 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 DULCES GABY SA DE CV come from?

All FDA import refusal data for DULCES GABY 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.