Bioriginal Europe
⚠️ Moderate Risk
FEI: 3005948845 • Den Bommel, Zuid-Holland • NETHERLANDS
FEI Number
3005948845
Location
Den Bommel, Zuid-Holland
Country
NETHERLANDSAddress
Bosland 40, , Den Bommel, Zuid-Holland, Netherlands
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
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.
ALLERGEN
the label fails to declare all major food allergens present in the product, as required by section 403(w)(1).
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
Refusal History
Frequently Asked Questions
What is Bioriginal Europe's FDA import refusal history?
Bioriginal Europe (FEI: 3005948845) has 1 FDA import refusal record(s) in our database, spanning from 10/14/2010 to 10/14/2010.
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. Bioriginal Europe's FEI number is 3005948845.
What types of violations has Bioriginal Europe received?
Bioriginal Europe 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 Bioriginal Europe come from?
All FDA import refusal data for Bioriginal Europe 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.