Berner Oy
✅ Low Risk
FEI: 3005980985 • Helsinki, Uusimaa • FINLAND
FEI Number
3005980985
Location
Helsinki, Uusimaa
Country
FINLANDAddress
Kosmetiikka, Etelaranta 4 B, Helsinki, Uusimaa, Finland
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
Required label or labeling appears to not be in English in violation of 21 C.F.R. 801.15(c)(1)
NO 510(K)
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.
Refusal History
Frequently Asked Questions
What is Berner Oy's FDA import refusal history?
Berner Oy (FEI: 3005980985) has 1 FDA import refusal record(s) in our database, spanning from 9/13/2013 to 9/13/2013.
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. Berner Oy's FEI number is 3005980985.
What types of violations has Berner Oy received?
Berner Oy has been cited for 2 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 Berner Oy come from?
All FDA import refusal data for Berner Oy 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.