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FABRICA DE DULCES MARY

⚠️ Moderate Risk

FEI: 3029816879 • Mexico • MEXICO

FEI

FEI Number

3029816879

📍

Location

Mexico

🇲🇽

Country

MEXICO
🏢

Address

Profesora No. 114, Col.Metropolitana 1a. Seccion C.P. 57730 Cd. Nezahualcoyotl, Edo De Mexico, Mexico, , Mexico

Moderate Risk

FDA Import Risk Assessment

37.2
LowModerateHighCritical

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

Statistics

1
Total Refusals
3
Unique Violations
12/9/2023
Latest Refusal
12/9/2023
Earliest Refusal

Score Breakdown

Violation Severity
53.3×40%
Refusal Volume
11.2×30%
Recency
57.7×20%
Frequency
10.0×10%
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

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).

2741×

COLOR LBLG

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

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)).

Refusal History

DateProductViolationsDivision
12/9/2023
33LGT09MARSHMALLOW CANDY, SOFT, WITHOUT NUTS AND FRUIT (WITHOUT CHOCOLATE)
11UNSAFE COL
274COLOR LBLG
324NO ENGLISH
Division of Southwest Imports (DSWI)

Frequently Asked Questions

What is FABRICA DE DULCES MARY's FDA import refusal history?

FABRICA DE DULCES MARY (FEI: 3029816879) has 1 FDA import refusal record(s) in our database, spanning from 12/9/2023 to 12/9/2023.

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 MARY's FEI number is 3029816879.

What types of violations has FABRICA DE DULCES MARY received?

FABRICA DE DULCES MARY has been cited for 3 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 MARY come from?

All FDA import refusal data for FABRICA DE DULCES MARY 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.