EXPOTUNA S.A.
⚠️ High Risk
FEI: 3010142422 • Guayaquil, Guayas • ECUADOR
FEI Number
3010142422
Location
Guayaquil, Guayas
Country
ECUADORAddress
Km. 15.5 Via a Daule, Av. Rosavin, Y Asbestos, Mz. F6 Solares 21 y 22, Guayaquil, Guayas, Ecuador
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable violations.
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
FILTHY
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the article appears to consist in whole or in part of a filthy, putrid, or decomposed substance or be otherwise unfit for food.
HISTAMINE
The article appears to bear or contain histamine, a poisonous and deleterious substance in such quantity as ordinarily renders it injurious to health.
MFR INSAN
The article is subject to refusal of admission pursuant to section 801(a)(1) in that the article appears to have been manufactured, processed, or packed under insanitary conditions.
LACKS FIRM
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(e)(1) of the FD&C Act in that the food is in package form and the label fails to bear the name and place of business of the manufacturer, packer, or distributor.
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 11/27/2017 | 16AVT51MAHI MAHI | Division of Southeast Imports (DSEI) | |
| 4/10/2017 | 16AVT51MAHI MAHI | Division of Southeast Imports (DSEI) | |
| 2/3/2017 | 16AVT51MAHI MAHI | Florida District Office (FLA-DO) | |
| 10/14/2016 | 16AVT51MAHI MAHI | 249FILTHY | Florida District Office (FLA-DO) |
| 10/14/2016 | 16AVT51MAHI MAHI | 249FILTHY | Florida District Office (FLA-DO) |
| 10/14/2016 | 16AVT51MAHI MAHI | 249FILTHY | Florida District Office (FLA-DO) |
| 10/3/2016 | 16AVT51MAHI MAHI | 249FILTHY | Florida District Office (FLA-DO) |
| 10/3/2016 | 16AVT51MAHI MAHI | 249FILTHY | Florida District Office (FLA-DO) |
| 8/26/2016 | 16AVT51MAHI MAHI | 249FILTHY | Florida District Office (FLA-DO) |
| 2/17/2016 | 16AGC45TUNA (ALBACORE, YELLOWFIN, BLUEFIN, SKIPJACK, ETC.) | Florida District Office (FLA-DO) | |
| 8/27/2015 | 16AVT51MAHI MAHI | 249FILTHY | Florida District Office (FLA-DO) |
| 8/10/2015 | 16AVT51MAHI MAHI | 249FILTHY | Division of Southeast Imports (DSEI) |
| 3/16/2011 | 16AGC51MAHI MAHI | 2360HISTAMINE | Florida District Office (FLA-DO) |
Frequently Asked Questions
What is EXPOTUNA S.A.'s FDA import refusal history?
EXPOTUNA S.A. (FEI: 3010142422) has 13 FDA import refusal record(s) in our database, spanning from 3/16/2011 to 11/27/2017.
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. EXPOTUNA S.A.'s FEI number is 3010142422.
What types of violations has EXPOTUNA S.A. received?
EXPOTUNA S.A. has been cited for 5 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 EXPOTUNA S.A. come from?
All FDA import refusal data for EXPOTUNA S.A. 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.