ImportRefusal LogoImportRefusal

Dulceria San Luis

⚠️ Moderate Risk

FEI: 3011158624 • Irapuato, Guanajuato • MEXICO

FEI

FEI Number

3011158624

📍

Location

Irapuato, Guanajuato

🇲🇽

Country

MEXICO
🏢

Address

Calle Rio Nilo 543, Col. CUARTO DIA, Irapuato, Guanajuato, Mexico

Moderate Risk

FDA Import Risk Assessment

25.7
LowModerateHighCritical

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

Statistics

3
Total Refusals
7
Unique Violations
2/23/2016
Latest Refusal
2/12/2016
Earliest Refusal

Score Breakdown

Violation Severity
40.0×40%
Refusal Volume
22.3×30%
Recency
0.0×20%
Frequency
30.0×10%
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

3283×

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.

2563×

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)).

3212×

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.

4822×

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.

2741×

COLOR LBLG

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

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.

111×

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).

Refusal History

DateProductViolationsDivision
2/23/2016
33HGT05CANDY BAR OR PIECES (NOT CARAMEL OR FONDANT), SOFT, WITH COCONUT (WITHOUT CHOCOLATE)
11UNSAFE COL
218LIST INGRE
256INCONSPICU
274COLOR LBLG
321LACKS N/C
328USUAL NAME
Division of Southwest Imports (DSWI)
2/23/2016
33GGT05CANDY BAR OR PIECES (NOT CARAMEL OR FONDANT), SOFT, WITH NUTS OR NUT PRODUCTS (WITHOUT CHOCOLATE)
256INCONSPICU
321LACKS N/C
328USUAL NAME
482NUTRIT LBL
Division of Southwest Imports (DSWI)
2/12/2016
23BGT07PEANUT, SHELLED
256INCONSPICU
328USUAL NAME
482NUTRIT LBL
Division of Southwest Imports (DSWI)

Frequently Asked Questions

What is Dulceria San Luis's FDA import refusal history?

Dulceria San Luis (FEI: 3011158624) has 3 FDA import refusal record(s) in our database, spanning from 2/12/2016 to 2/23/2016.

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. Dulceria San Luis's FEI number is 3011158624.

What types of violations has Dulceria San Luis received?

Dulceria San Luis has been cited for 7 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 Dulceria San Luis come from?

All FDA import refusal data for Dulceria San Luis 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.