Yoleni's Hellas SMLTD
⚠️ Moderate Risk
FEI: 3014312218 • Athens, Attica • GREECE
FEI Number
3014312218
Location
Athens, Attica
Country
GREECEAddress
9 Solonos St, , Athens, Attica, Greece
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
LACKS N/C
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(e)(2) of the FD&C Act in that the food is in package form and the label fails to bear an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count in accordance with Section 403(e)(2) of the FD&C Act.
LACKS FIRM
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(e)(1) of the FD&C Act in that the food is in package form and the label fails to bear the name and place of business of the manufacturer, packer, or distributor.
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.
ALLERGEN
the label fails to declare all major food allergens present in the product, as required by section 403(w)(1).
USUAL NAME
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(i)(1) of the FD&C Act in that the label fails to bear the common or usual name of the food, if any there be.
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 |
|---|---|---|---|
| 6/14/2018 | 18YCT99VEGETABLE PROTEIN PRODUCTS NOT ELSEWHERE MENTIONED, N.E.C. | Division of Northeast Imports (DNEI) | |
| 6/14/2018 | 25YCH99VEGETABLE & VEGETABLE PRODUCTS NOT MENTIONED ELSEWHERE, N.E.C. | Division of Northeast Imports (DNEI) | |
| 6/14/2018 | 18YCT99VEGETABLE PROTEIN PRODUCTS NOT ELSEWHERE MENTIONED, N.E.C. | Division of Northeast Imports (DNEI) | |
| 6/14/2018 | 24VCT01ARTICHOKE, WITH SAUCE | Division of Northeast Imports (DNEI) |
Frequently Asked Questions
What is Yoleni's Hellas SMLTD's FDA import refusal history?
Yoleni's Hellas SMLTD (FEI: 3014312218) has 4 FDA import refusal record(s) in our database, spanning from 6/14/2018 to 6/14/2018.
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. Yoleni's Hellas SMLTD's FEI number is 3014312218.
What types of violations has Yoleni's Hellas SMLTD received?
Yoleni's Hellas SMLTD has been cited for 7 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 Yoleni's Hellas SMLTD come from?
All FDA import refusal data for Yoleni's Hellas SMLTD 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.