Academie Scientifique De Beaute
⚠️ Moderate Risk
FEI: 1000276682 • Colombes, Hauts de Seine • FRANCE
FEI Number
1000276682
Location
Colombes, Hauts de Seine
Country
FRANCEAddress
83 avenue Henri Barbusse, , Colombes, Hauts de Seine, 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
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).
DIRECTIONS
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.
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).
NO ENGLISH
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(f) of the FD&C Act in that any word, statement, or other information required by or under the authority of the FD&C Act to appear on the label or labeling is not prominently placed thereon with such conspicuousness (as compared with other words, statements, designs, or devices, in the labeling) and in such terms as to render it likely to be read and understood by the ordinary individual under customary terms of purchase and use (for example, label contains information in two or more languages but fails to repeat all required information in both languages in accordance with 21 CFR 101.15(c)(2), or label fails to include all required information in English in accordance with 21 CFR 101.15(c)(1), except in the case of articles distributed solely in the Commonwealth of Puerto Rico or in a Territory where the predominant language is one other than English)).
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
DRUG NAME
The article appears to be a drug and fails to bear the proprietary or established name and/or name and quantity of each active ingredient.
COSM COLOR
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to contain a color additive which is unsafe within the meaning of Section 721(a) which renders it adulterated under Section 601(e).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 4/4/2013 | 53LC06MOISTURIZING (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Southwest Import District Office (SWI-DO) |
| 4/4/2013 | 53LC08PASTE MASKS (MUD PACKS) (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Southwest Import District Office (SWI-DO) |
| 4/4/2013 | 53LC06MOISTURIZING (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Southwest Import District Office (SWI-DO) |
| 3/4/2013 | 53LC06MOISTURIZING (SKIN CARE PREPARATIONS) | 197COSM COLOR | Southwest Import District Office (SWI-DO) |
| 9/17/2007 | 53YC99OTHER COSMETIC AND COSMETIC PRODUCTS, N.E.C. | Southwest Import District Office (SWI-DO) | |
| 9/17/2007 | 53LD99OTHER SKIN CARE PREPARATIONS, N.E.C. | Southwest Import District Office (SWI-DO) | |
| 9/17/2007 | 62WAL17ALUMINUM CHLORIDE ASTRINGENT/ANTI-PERSPIRANT) | Southwest Import District Office (SWI-DO) | |
| 9/17/2007 | 53YC99OTHER COSMETIC AND COSMETIC PRODUCTS, N.E.C. | Southwest Import District Office (SWI-DO) | |
| 9/17/2007 | 53YC99OTHER COSMETIC AND COSMETIC PRODUCTS, N.E.C. | Southwest Import District Office (SWI-DO) | |
| 9/17/2007 | 53YC99OTHER COSMETIC AND COSMETIC PRODUCTS, N.E.C. | Southwest Import District Office (SWI-DO) | |
| 9/17/2007 | 53YC99OTHER COSMETIC AND COSMETIC PRODUCTS, N.E.C. | Southwest Import District Office (SWI-DO) | |
| 6/14/2002 | 66PAY99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Academie Scientifique De Beaute's FDA import refusal history?
Academie Scientifique De Beaute (FEI: 1000276682) has 12 FDA import refusal record(s) in our database, spanning from 6/14/2002 to 4/4/2013.
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. Academie Scientifique De Beaute's FEI number is 1000276682.
What types of violations has Academie Scientifique De Beaute received?
Academie Scientifique De Beaute has been cited for 8 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 Academie Scientifique De Beaute come from?
All FDA import refusal data for Academie Scientifique De Beaute 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.