Soitgar S.A.
⚠️ Moderate Risk
FEI: 3003621885 • Guayaquil, Guayas • ECUADOR
FEI Number
3003621885
Location
Guayaquil, Guayas
Country
ECUADORAddress
Via Daule Calle Casuarina Y Mirtos 8, , Guayaquil, 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
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 1/14/2003 | 21SFE08PLANTAIN (SUBTROPICAL AND TROPICAL FRUIT) | 62NEEDS FCE | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Soitgar S.A.'s FDA import refusal history?
Soitgar S.A. (FEI: 3003621885) has 1 FDA import refusal record(s) in our database, spanning from 1/14/2003 to 1/14/2003.
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. Soitgar S.A.'s FEI number is 3003621885.
What types of violations has Soitgar S.A. received?
Soitgar 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 Soitgar S.A. come from?
All FDA import refusal data for Soitgar 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.