Export Andina Ltda
⚠️ Moderate Risk
FEI: 3006033280 • Bogota • COLOMBIA
FEI Number
3006033280
Location
Bogota
Country
COLOMBIAAddress
Avenida El Dorado No 98-50, , Bogota, , Colombia
Moderate Risk
FDA Import Risk Assessment
This firm has a moderate history of FDA import refusals. Some attention may be warranted.
Statistics
Score Breakdown
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
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)).
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
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).
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.
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.
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
| Date | Product | Violations | Division |
|---|---|---|---|
| 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 | Florida District Office (FLA-DO) | |
| 2/2/2009 | 03RMT01CAKE WITHOUT CUSTARD OR CREAM FILLING | 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) | Florida District Office (FLA-DO) | |
| 2/2/2009 | 33SHY99CANDY SPECIALTIES, N.E.C. (WITHOUT CHOCOLATE) | Florida District Office (FLA-DO) | |
| 2/2/2009 | 07AGE99BAKED SNACK FOOD, N.E.C. | Florida District Office (FLA-DO) | |
| 2/2/2009 | 07AGE99BAKED SNACK FOOD, N.E.C. | 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. | 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.