Helio S.A.
⚠️ Moderate Risk
FEI: 3006321277 • Leszno, Mazowieckie • POLAND
FEI Number
3006321277
Location
Leszno, Mazowieckie
Country
POLANDAddress
Ul. Stoleczna 26, , Leszno, Mazowieckie, Poland
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
COLOR LBLG
The article appears to contain an artificial coloring and it fails to bear labeling stating that fact.
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).
SULFITELBL
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded because 1) it appears to contain sulfites but the label fails to declare the presence of sulfites, a fact material to sulfite-sensitive individuals who must avoid the ingredient due to potential health consequences from its consumption, and 2) it appears the food is fabricated from two or more ingredients and the label does not list the common or usual name of each ingredient.
EXCESS SUL
The article appears to contain excessive sulfites, a poisonous and deleterious substance which may render it injurious to health.
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.
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.
UNDER PRC
The article appears to have inadequate processing in having been prepared, packed, or held under insanitary conditions whereby it may have been rendered injurious to health.
LIST INGRE
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)(2) of the FD&C Act in that it is fabricated from two or more ingredients and the label fails to bear the common or usual name of each such ingredient and/or the article purports to be a beverage containing vegetable or fruit juice, but does not bear a statement with appropriate prominence on the information panel of the total percentage of such fruit or vegetable juice contained in the food.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 7/10/2013 | 21BFT99MIXED FRUIT, DRIED OR PASTE, N.E.C., | Chicago District Office (CHI-DO) | |
| 3/5/2013 | 21BDT99MIXED FRUIT, DRIED OR PASTE, N.E.C., | Chicago District Office (CHI-DO) | |
| 1/4/2013 | 21BGH99MIXED FRUIT, DRIED OR PASTE, N.E.C., | Division of Northern Border Imports (DNBI) | |
| 12/20/2012 | 21BBT99MIXED FRUIT, DRIED OR PASTE, N.E.C., | 11UNSAFE COL | New York District Office (NYK-DO) |
| 6/4/2010 | 23EEE99NUT, SPREAD, N.E.C. | 181UNDER PRC | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Helio S.A.'s FDA import refusal history?
Helio S.A. (FEI: 3006321277) has 5 FDA import refusal record(s) in our database, spanning from 6/4/2010 to 7/10/2013.
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. Helio S.A.'s FEI number is 3006321277.
What types of violations has Helio S.A. received?
Helio S.A. has been cited for 8 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 Helio S.A. come from?
All FDA import refusal data for Helio 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.