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Gustar Sa

⚠️ Moderate Risk

FEI: 3004134240 • Sabaneta • COLOMBIA

FEI

FEI Number

3004134240

📍

Location

Sabaneta

🇨🇴

Country

COLOMBIA
🏢

Address

4450 Cra Sur 175, , Sabaneta, , Colombia

Moderate Risk

FDA Import Risk Assessment

39.0
LowModerateHighCritical

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

Statistics

4
Total Refusals
2
Unique Violations
10/9/2013
Latest Refusal
8/11/2010
Earliest Refusal

Score Breakdown

Violation Severity
75.0×40%
Refusal Volume
25.9×30%
Recency
0.0×20%
Frequency
12.6×10%
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

37213×

PESTICIDE2

The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be adulterated because it contains a pesticide chemical, which is in violation of section 402(a)(2)(B). Contains:

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
10/9/2013
21TGT04GUAVA, DRIED OR PASTE
3721PESTICIDE2
New York District Office (NYK-DO)
10/9/2013
21TGT04GUAVA, DRIED OR PASTE
3721PESTICIDE2
New York District Office (NYK-DO)
10/9/2013
21TGT04GUAVA, DRIED OR PASTE
3721PESTICIDE2
New York District Office (NYK-DO)
8/11/2010
03RGT35PASTRY, FRUIT OR JELLY FILLED, WITHOUT CUSTARD OR CREAM FILLING
324NO ENGLISH
New York District Office (NYK-DO)

Frequently Asked Questions

What is Gustar Sa's FDA import refusal history?

Gustar Sa (FEI: 3004134240) has 4 FDA import refusal record(s) in our database, spanning from 8/11/2010 to 10/9/2013.

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. Gustar Sa's FEI number is 3004134240.

What types of violations has Gustar Sa received?

Gustar Sa has been cited for 2 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 Gustar Sa come from?

All FDA import refusal data for Gustar Sa 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.