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Empaquetados el Trece SAS

✅ Low Risk

FEI: 3013447251 • Itagui • COLOMBIA

FEI

FEI Number

3013447251

📍

Location

Itagui

🇨🇴

Country

COLOMBIA
🏢

Address

Central Mayorista, Bloque 13, Local 15., Itagui, , Colombia

Low Risk

FDA Import Risk Assessment

21.1
LowModerateHighCritical

This firm has a minimal history of FDA import refusals with low-severity violations.

Statistics

3
Total Refusals
1
Unique Violations
8/1/2018
Latest Refusal
4/28/2017
Earliest Refusal

Score Breakdown

Violation Severity
30.0×40%
Refusal Volume
22.3×30%
Recency
0.0×20%
Frequency
23.8×10%
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

3243×

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
8/1/2018
24EYY99BEAN AND PEA SPROUTS, N.E.C. (VEGETABLE)
324NO ENGLISH
Division of Southeast Imports (DSEI)
8/1/2018
24AYY99BEANS, CORN, AND PEA, N.E.C. (VEGETABLE)
324NO ENGLISH
Division of Southeast Imports (DSEI)
4/28/2017
36AGT03CANE SUGAR (SUCROSE)
324NO ENGLISH
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is Empaquetados el Trece SAS's FDA import refusal history?

Empaquetados el Trece SAS (FEI: 3013447251) has 3 FDA import refusal record(s) in our database, spanning from 4/28/2017 to 8/1/2018.

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. Empaquetados el Trece SAS's FEI number is 3013447251.

What types of violations has Empaquetados el Trece SAS received?

Empaquetados el Trece SAS has been cited for 1 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 Empaquetados el Trece SAS come from?

All FDA import refusal data for Empaquetados el Trece SAS 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.