Dulfix S.A.
⚠️ Moderate Risk
FEI: 3004654360 • Ciudadela, Buenos Aires • ARGENTINA
FEI Number
3004654360
Location
Ciudadela, Buenos Aires
Country
ARGENTINAAddress
Calle Dr Juan Jose Paso 962, , Ciudadela, Buenos Aires, Argentina
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 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.
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 1/30/2004 | 22JGB99OTHER FRUIT AND FRUIT PRODUCTS, JAM, JELLY, PRESERVES, MARMALADE, BUTTER OR CANDIED, N.E.C. | 11UNSAFE COL | New York District Office (NYK-DO) |
| 10/30/2003 | 25JET12SWEET POTATO (ROOT & TUBER VEGETABLE) | 83NO PROCESS | Los Angeles District Office (LOS-DO) |
| 10/30/2003 | 25JET12SWEET POTATO (ROOT & TUBER VEGETABLE) | 83NO PROCESS | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Dulfix S.A.'s FDA import refusal history?
Dulfix S.A. (FEI: 3004654360) has 3 FDA import refusal record(s) in our database, spanning from 10/30/2003 to 1/30/2004.
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. Dulfix S.A.'s FEI number is 3004654360.
What types of violations has Dulfix S.A. received?
Dulfix S.A. has been cited for 2 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 Dulfix S.A. come from?
All FDA import refusal data for Dulfix 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.