Tropical Foods S.A.
⚠️ High Risk
FEI: 3006761757 • Pedro Vicente Maldonado, Pichincha • ECUADOR
FEI Number
3006761757
Location
Pedro Vicente Maldonado, Pichincha
Country
ECUADORAddress
Km 113 Via Puerto Quito 137, , Pedro Vicente Maldonado, Pichincha, 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
NO PROCESS
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the manufacturer's failure to file a scheduled process demonstrates that the product is not being manufactured under the mandatory provisions of 21 CFR Part 108 and therefore appears to have been manufactured, processed, or packed, under insanitary conditions whereby it may have been rendered injurious to health.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 11/21/2024 | 25JEE16CASSAVA (ROOT AND TUBER VEGETABLE) | 83NO PROCESS | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Tropical Foods S.A.'s FDA import refusal history?
Tropical Foods S.A. (FEI: 3006761757) has 1 FDA import refusal record(s) in our database, spanning from 11/21/2024 to 11/21/2024.
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. Tropical Foods S.A.'s FEI number is 3006761757.
What types of violations has Tropical Foods S.A. received?
Tropical Foods S.A. has been cited for 1 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 Tropical Foods S.A. come from?
All FDA import refusal data for Tropical Foods 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.