Agricola E. Industrial Ecuaplantation, S.A.
⚠️ Moderate Risk
FEI: 1000253627 • Duran, Guayas • ECUADOR
FEI Number
1000253627
Location
Duran, Guayas
Country
ECUADORAddress
Km 4.5 Via Duran Tambo, , Duran, Guayas, Ecuador
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
INSANITARY
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to have been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health.
NEEDS FCE
It appears the manufacturer is not registered as a low acid canned food or acidified food manufacturer pursuant to 21 CFR 108.25(c)(1) or 108.35(c)(1).
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 |
|---|---|---|---|
| 1/19/2010 | 21RGT02BANANA (SUBTROPICAL AND TROPICAL FRUIT PUREES) | 306INSANITARY | New York District Office (NYK-DO) |
| 1/19/2010 | 21RGT02BANANA (SUBTROPICAL AND TROPICAL FRUIT PUREES) | 306INSANITARY | New York District Office (NYK-DO) |
| 4/23/2002 | 21RGI02BANANA (SUBTROPICAL AND TROPICAL FRUIT PUREES) | Florida District Office (FLA-DO) |
Frequently Asked Questions
What is Agricola E. Industrial Ecuaplantation, S.A.'s FDA import refusal history?
Agricola E. Industrial Ecuaplantation, S.A. (FEI: 1000253627) has 3 FDA import refusal record(s) in our database, spanning from 4/23/2002 to 1/19/2010.
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. Agricola E. Industrial Ecuaplantation, S.A.'s FEI number is 1000253627.
What types of violations has Agricola E. Industrial Ecuaplantation, S.A. received?
Agricola E. Industrial Ecuaplantation, S.A. has been cited for 3 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 Agricola E. Industrial Ecuaplantation, S.A. come from?
All FDA import refusal data for Agricola E. Industrial Ecuaplantation, 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.