Oriflame Cosmetics Sa A Luxembourg
⚠️ Moderate Risk
FEI: 3005013762 • Fribourg, Fribourg • SWITZERLAND
FEI Number
3005013762
Location
Fribourg, Fribourg
Country
SWITZERLANDAddress
Succursale De Fribourgroute Des, , Fribourg, Fribourg, Switzerland
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
NOT LISTED
It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).
CSTIC LBLG
The labeling appears to fail to comply with cosmetic labeling requirements of Section 602(a), and/or (b), and/or (c), and as identified by 21 C.F.R. Part 701.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 8/3/2005 | 66PBY99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | 118NOT LISTED | Florida District Office (FLA-DO) |
| 8/3/2005 | 66PBY07OXYBENZONE (ULTRAVIOLET SCREEN/SUNSCREEN) | 118NOT LISTED | Florida District Office (FLA-DO) |
| 8/3/2005 | 66PBY99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | 118NOT LISTED | Florida District Office (FLA-DO) |
| 8/3/2005 | 66PBY99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | 118NOT LISTED | Florida District Office (FLA-DO) |
| 8/3/2005 | 66PBY07OXYBENZONE (ULTRAVIOLET SCREEN/SUNSCREEN) | 118NOT LISTED | Florida District Office (FLA-DO) |
| 6/15/2005 | 64ABY20TRICLOSAN (DISINFECTANT) | 118NOT LISTED | Florida District Office (FLA-DO) |
| 6/10/2005 | 53CK02EYELINER (EYE MAKEUP PREPARATIONS) | 471CSTIC LBLG | Florida District Office (FLA-DO) |
Frequently Asked Questions
What is Oriflame Cosmetics Sa A Luxembourg's FDA import refusal history?
Oriflame Cosmetics Sa A Luxembourg (FEI: 3005013762) has 7 FDA import refusal record(s) in our database, spanning from 6/10/2005 to 8/3/2005.
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. Oriflame Cosmetics Sa A Luxembourg's FEI number is 3005013762.
What types of violations has Oriflame Cosmetics Sa A Luxembourg received?
Oriflame Cosmetics Sa A Luxembourg 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 Oriflame Cosmetics Sa A Luxembourg come from?
All FDA import refusal data for Oriflame Cosmetics Sa A Luxembourg 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.