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C.I.Comep Y Cia. Ltda.

✅ Low Risk

FEI: 3006702843 • Medellin • COLOMBIA

FEI

FEI Number

3006702843

📍

Location

Medellin

🇨🇴

Country

COLOMBIA
🏢

Address

Carrera 43 A No. 1-85 Of 513ed. Caja, , Medellin, , Colombia

Low Risk

FDA Import Risk Assessment

24.3
LowModerateHighCritical

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

Statistics

3
Total Refusals
4
Unique Violations
11/9/2010
Latest Refusal
8/14/2009
Earliest Refusal

Score Breakdown

Violation Severity
38.0×40%
Refusal Volume
22.3×30%
Recency
0.0×20%
Frequency
24.2×10%
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

4732×

LABELING

The article appears in violation of FPLA because of its placement, form and/or contents statement.

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.

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)).

4821×

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.

Refusal History

DateProductViolationsDivision
11/9/2010
03YFT09TORTILLAS
482NUTRIT LBL
Florida District Office (FLA-DO)
8/14/2009
03YFT09TORTILLAS
324NO ENGLISH
473LABELING
Florida District Office (FLA-DO)
8/14/2009
03YFT09TORTILLAS
218LIST INGRE
473LABELING
Florida District Office (FLA-DO)

Frequently Asked Questions

What is C.I.Comep Y Cia. Ltda.'s FDA import refusal history?

C.I.Comep Y Cia. Ltda. (FEI: 3006702843) has 3 FDA import refusal record(s) in our database, spanning from 8/14/2009 to 11/9/2010.

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. C.I.Comep Y Cia. Ltda.'s FEI number is 3006702843.

What types of violations has C.I.Comep Y Cia. Ltda. received?

C.I.Comep Y Cia. Ltda. has been cited for 4 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 C.I.Comep Y Cia. Ltda. come from?

All FDA import refusal data for C.I.Comep Y Cia. Ltda. 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.