Institut Esthederm
⚠️ Moderate Risk
FEI: 1000171494 • Paris, Paris • FRANCE
FEI Number
1000171494
Location
Paris, Paris
Country
FRANCEAddress
3 Rue Palatine, , 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
COSMETLBLG
It appears that the cosmetic consists of two or more ingredients and the label does not list the common or usual name of each ingredient.
UNAPPROVED
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA).
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 9/10/2014 | 53LC06MOISTURIZING (SKIN CARE PREPARATIONS) | 75UNAPPROVED | New England District Office (NWE-DO) |
| 3/26/2008 | 53CC05EYE MAKEUP REMOVER (EYE MAKEUP PREPARATIONS) | 75UNAPPROVED | Baltimore District Office (BLT-DO) |
| 3/26/2008 | 53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Baltimore District Office (BLT-DO) |
| 2/22/2007 | 53GY99OTHER MAKEUP PREPARATION, NOT FOR THE EYES, N.E.C. | 475COSMETLBLG | Florida District Office (FLA-DO) |
| 2/22/2007 | 53GY99OTHER MAKEUP PREPARATION, NOT FOR THE EYES, N.E.C. | 475COSMETLBLG | Florida District Office (FLA-DO) |
| 2/22/2007 | 53GY99OTHER MAKEUP PREPARATION, NOT FOR THE EYES, N.E.C. | Florida District Office (FLA-DO) |
Frequently Asked Questions
What is Institut Esthederm's FDA import refusal history?
Institut Esthederm (FEI: 1000171494) has 6 FDA import refusal record(s) in our database, spanning from 2/22/2007 to 9/10/2014.
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. Institut Esthederm's FEI number is 1000171494.
What types of violations has Institut Esthederm received?
Institut Esthederm 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 Institut Esthederm come from?
All FDA import refusal data for Institut Esthederm 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.