Ornellaia Tenuta-C To Dep Li
✅ Low Risk
FEI: 3008406534 • Bibbona, Leghorn • ITALY
FEI Number
3008406534
Location
Bibbona, Leghorn
Country
ITALYAddress
Via Bolgherese 191, , Bibbona, Leghorn, Italy
Low Risk
FDA Import Risk Assessment
This firm has a minimal history of FDA import refusals with low-severity 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 ENGLISH
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(f) of the FD&C Act in that any word, statement, or other information required by or under the authority of the FD&C Act to appear on the label or labeling is not prominently placed thereon with such conspicuousness (as compared with other words, statements, designs, or devices, in the labeling) and in such terms as to render it likely to be read and understood by the ordinary individual under customary terms of purchase and use (for example, label contains information in two or more languages but fails to repeat all required information in both languages in accordance with 21 CFR 101.15(c)(2), or label fails to include all required information in English in accordance with 21 CFR 101.15(c)(1), except in the case of articles distributed solely in the Commonwealth of Puerto Rico or in a Territory where the predominant language is one other than English)).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 5/21/2018 | 26CEB04OLIVE OIL, REFINED, SINGLE INGREDIENT | 324NO ENGLISH | Division of Southwest Imports (DSWI) |
Frequently Asked Questions
What is Ornellaia Tenuta-C To Dep Li's FDA import refusal history?
Ornellaia Tenuta-C To Dep Li (FEI: 3008406534) has 1 FDA import refusal record(s) in our database, spanning from 5/21/2018 to 5/21/2018.
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. Ornellaia Tenuta-C To Dep Li's FEI number is 3008406534.
What types of violations has Ornellaia Tenuta-C To Dep Li received?
Ornellaia Tenuta-C To Dep Li 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 Ornellaia Tenuta-C To Dep Li come from?
All FDA import refusal data for Ornellaia Tenuta-C To Dep Li 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.