Zigante Tartufi d.o.o.
⚠️ Moderate Risk
FEI: 3005461643 • Koper - Capodistria, Koper • SLOVENIA
FEI Number
3005461643
Location
Koper - Capodistria, Koper
Country
SLOVENIAAddress
Vanganelska Cesta / Strada Di Vanganello 8, , Koper - Capodistria, Koper, Slovenia
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).
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.
NUTRIT LBL
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded in that the label or labeling fails to bear the required nutrition information.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 10/24/2006 | 25QHO02TRUFFLE, PIECES AND STEMS, SLICED | Cincinnati District Office (CIN-DO) | |
| 10/24/2006 | 25QHO02TRUFFLE, PIECES AND STEMS, SLICED | Cincinnati District Office (CIN-DO) | |
| 10/24/2006 | 25QHO02TRUFFLE, PIECES AND STEMS, SLICED | Cincinnati District Office (CIN-DO) | |
| 10/24/2006 | 25QHE02TRUFFLE, PIECES AND STEMS, SLICED | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is Zigante Tartufi d.o.o.'s FDA import refusal history?
Zigante Tartufi d.o.o. (FEI: 3005461643) has 4 FDA import refusal record(s) in our database, spanning from 10/24/2006 to 10/24/2006.
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. Zigante Tartufi d.o.o.'s FEI number is 3005461643.
What types of violations has Zigante Tartufi d.o.o. received?
Zigante Tartufi d.o.o. 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 Zigante Tartufi d.o.o. come from?
All FDA import refusal data for Zigante Tartufi d.o.o. 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.