ImportRefusal LogoImportRefusal

Export Andina Ltda

⚠️ Moderate Risk

FEI: 3006033280 • Bogota • COLOMBIA

FEI

FEI Number

3006033280

📍

Location

Bogota

🇨🇴

Country

COLOMBIA
🏢

Address

Avenida El Dorado No 98-50, , Bogota, , Colombia

Moderate Risk

FDA Import Risk Assessment

42.6
LowModerateHighCritical

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

Statistics

31
Total Refusals
6
Unique Violations
6/8/2009
Latest Refusal
11/25/2008
Earliest Refusal

Score Breakdown

Violation Severity
39.7×40%
Refusal Volume
55.8×30%
Recency
0.0×20%
Frequency
100.0×10%
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

32418×

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)).

47310×

LABELING

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

113×

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).

2183×

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.

4823×

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.

641×

YELLOW #5

The food appears to bear or contain the color additive FD & C Yellow No. 5, which is not declared on the label per 21 CFR 74.705(a)(c) under section 721.

Refusal History

DateProductViolationsDivision
6/8/2009
33ACT12MIXED/ASSORTED HARD CANDIES W/NUT,NUT PRODS,SEEDS W/O COCONUT W/O CHOCOLATE
324NO ENGLISH
Florida District Office (FLA-DO)
6/8/2009
03AGT99BREAD/ROLLS/BUNS, N.E.C.
324NO ENGLISH
Florida District Office (FLA-DO)
2/2/2009
33SHY99CANDY SPECIALTIES, N.E.C. (WITHOUT CHOCOLATE)
482NUTRIT LBL
Florida District Office (FLA-DO)
2/2/2009
03RMT01CAKE WITHOUT CUSTARD OR CREAM FILLING
324NO ENGLISH
482NUTRIT LBL
Florida District Office (FLA-DO)
2/2/2009
03RMT01CAKE WITHOUT CUSTARD OR CREAM FILLING
324NO ENGLISH
64YELLOW #5
Florida District Office (FLA-DO)
2/2/2009
33SHY99CANDY SPECIALTIES, N.E.C. (WITHOUT CHOCOLATE)
324NO ENGLISH
Florida District Office (FLA-DO)
2/2/2009
33SHY99CANDY SPECIALTIES, N.E.C. (WITHOUT CHOCOLATE)
324NO ENGLISH
Florida District Office (FLA-DO)
2/2/2009
33SHY99CANDY SPECIALTIES, N.E.C. (WITHOUT CHOCOLATE)
324NO ENGLISH
Florida District Office (FLA-DO)
2/2/2009
03RMT01CAKE WITHOUT CUSTARD OR CREAM FILLING
324NO ENGLISH
Florida District Office (FLA-DO)
2/2/2009
03RMT01CAKE WITHOUT CUSTARD OR CREAM FILLING
324NO ENGLISH
Florida District Office (FLA-DO)
2/2/2009
07AGE99BAKED SNACK FOOD, N.E.C.
324NO ENGLISH
Florida District Office (FLA-DO)
2/2/2009
07AGE99BAKED SNACK FOOD, N.E.C.
324NO ENGLISH
Florida District Office (FLA-DO)
2/2/2009
07AGE99BAKED SNACK FOOD, N.E.C.
324NO ENGLISH
Florida District Office (FLA-DO)
2/2/2009
07AGE99BAKED SNACK FOOD, N.E.C.
324NO ENGLISH
Florida District Office (FLA-DO)
2/2/2009
07AGE99BAKED SNACK FOOD, N.E.C.
324NO ENGLISH
Florida District Office (FLA-DO)
2/2/2009
07AGE99BAKED SNACK FOOD, N.E.C.
324NO ENGLISH
Florida District Office (FLA-DO)
2/2/2009
33SHY99CANDY SPECIALTIES, N.E.C. (WITHOUT CHOCOLATE)
218LIST INGRE
482NUTRIT LBL
Florida District Office (FLA-DO)
2/2/2009
33SHY99CANDY SPECIALTIES, N.E.C. (WITHOUT CHOCOLATE)
218LIST INGRE
324NO ENGLISH
Florida District Office (FLA-DO)
2/2/2009
07AGE99BAKED SNACK FOOD, N.E.C.
218LIST INGRE
324NO ENGLISH
Florida District Office (FLA-DO)
2/2/2009
07AGE99BAKED SNACK FOOD, N.E.C.
11UNSAFE COL
324NO ENGLISH
Florida District Office (FLA-DO)
2/2/2009
07AGE99BAKED SNACK FOOD, N.E.C.
11UNSAFE COL
Florida District Office (FLA-DO)
11/25/2008
07AGE99BAKED SNACK FOOD, N.E.C.
473LABELING
Florida District Office (FLA-DO)
11/25/2008
07AGE99BAKED SNACK FOOD, N.E.C.
473LABELING
Florida District Office (FLA-DO)
11/25/2008
07AGE99BAKED SNACK FOOD, N.E.C.
473LABELING
Florida District Office (FLA-DO)
11/25/2008
07AGE99BAKED SNACK FOOD, N.E.C.
473LABELING
Florida District Office (FLA-DO)
11/25/2008
07AGE99BAKED SNACK FOOD, N.E.C.
473LABELING
Florida District Office (FLA-DO)
11/25/2008
07AGE99BAKED SNACK FOOD, N.E.C.
473LABELING
Florida District Office (FLA-DO)
11/25/2008
07AGE99BAKED SNACK FOOD, N.E.C.
473LABELING
Florida District Office (FLA-DO)
11/25/2008
07AGE99BAKED SNACK FOOD, N.E.C.
473LABELING
Florida District Office (FLA-DO)
11/25/2008
07AGE99BAKED SNACK FOOD, N.E.C.
473LABELING
Florida District Office (FLA-DO)
11/25/2008
07AGE99BAKED SNACK FOOD, N.E.C.
11UNSAFE COL
473LABELING
Florida District Office (FLA-DO)

Frequently Asked Questions

What is Export Andina Ltda's FDA import refusal history?

Export Andina Ltda (FEI: 3006033280) has 31 FDA import refusal record(s) in our database, spanning from 11/25/2008 to 6/8/2009.

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. Export Andina Ltda's FEI number is 3006033280.

What types of violations has Export Andina Ltda received?

Export Andina Ltda has been cited for 6 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 Export Andina Ltda come from?

All FDA import refusal data for Export Andina 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.