Clarins Sa
⚠️ Moderate Risk
FEI: 3011814513 • Paris, Paris • FRANCE
FEI Number
3011814513
Location
Paris, Paris
Country
FRANCEAddress
12 avenue de la Porte des Ternes, , Paris, Paris, France
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
FALSE
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose labeling appears to be false or misleading.
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 7/24/2020 | 62HAL05ETHYL ALCOHOL (ANTI-MICROBIAL) | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 12/7/2015 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | 223FALSE | Florida District Office (FLA-DO) |
| 12/7/2015 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | 223FALSE | Florida District Office (FLA-DO) |
| 12/7/2015 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | 223FALSE | Florida District Office (FLA-DO) |
Frequently Asked Questions
What is Clarins Sa's FDA import refusal history?
Clarins Sa (FEI: 3011814513) has 4 FDA import refusal record(s) in our database, spanning from 12/7/2015 to 7/24/2020.
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. Clarins Sa's FEI number is 3011814513.
What types of violations has Clarins Sa received?
Clarins Sa 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 Clarins Sa come from?
All FDA import refusal data for Clarins Sa 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.