Ets Diana De Beaute
⚠️ High Risk
FEI: 3002054792 • Beyrouth • LEBANON
FEI Number
3002054792
Location
Beyrouth
Country
LEBANONAddress
P.O. Box 11-7599, , Beyrouth, , Lebanon
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable 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
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).
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
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
CONTAINER
The container appears to be composed, in whole or in part, of a poisonous or deleterious substance which may render the contents injurious to health.
POISONOUS
The article is subject to refusal of admission pursuant Section 801(a)(3) in that The cosmetic appears to bear or contain a poisonous or deleterious substance which may render it injurious to users under the conditions prescribed in the labeling thereof, or, under such conditions of use as are customary or usual.
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.
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.
N-RX INACT
The article appears to be a nonprescription drug and fails to bear the established name of each inactive ingredient in alphabetical order on the outside container of the retail package.
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 9/15/2022 | 53LC99OTHER SKIN CARE PREPARATIONS, N.E.C. | Division of Southeast Imports (DSEI) | |
| 10/31/2014 | 53LC99OTHER SKIN CARE PREPARATIONS, N.E.C. | New Orleans District Office (NOL-DO) | |
| 10/3/2013 | 64XBY99KERATOLYTIC N.E.C. | New Orleans District Office (NOL-DO) | |
| 8/28/2013 | 66VCY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 7/17/2012 | 53LY99OTHER SKIN CARE PREPARATIONS, N.E.C. | 314CONTAINER | New Orleans District Office (NOL-DO) |
| 7/17/2012 | 53LY99OTHER SKIN CARE PREPARATIONS, N.E.C. | 314CONTAINER | New Orleans District Office (NOL-DO) |
| 7/17/2012 | 53LY99OTHER SKIN CARE PREPARATIONS, N.E.C. | 314CONTAINER | New Orleans District Office (NOL-DO) |
| 7/17/2012 | 66YDY99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 7/13/2012 | 53LY99OTHER SKIN CARE PREPARATIONS, N.E.C. | New Orleans District Office (NOL-DO) | |
| 6/12/2012 | 53L99OTHER SKIN CARE PREPARATIONS, N.E.C. | 310POISONOUS | New Orleans District Office (NOL-DO) |
| 5/11/2012 | 53LC99OTHER SKIN CARE PREPARATIONS, N.E.C. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 8/9/2011 | 53LC99OTHER SKIN CARE PREPARATIONS, N.E.C. | 310POISONOUS | Minneapolis District Office (MIN-DO) |
| 11/4/2010 | 53JY01BATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS) | 75UNAPPROVED | Minneapolis District Office (MIN-DO) |
| 10/13/2009 | 66VBJ99MISCELLANEOUS PATENT MEDICINES, ETC. | Seattle District Office (SEA-DO) | |
| 6/5/2009 | 53GC09FACE MAKEUP KITS (MAKEUP PREPARATIONS, NOT FOR EYES) | 75UNAPPROVED | Southwest Import District Office (SWI-DO) |
| 3/18/2009 | 66VAJ99MISCELLANEOUS PATENT MEDICINES, ETC. | New York District Office (NYK-DO) | |
| 3/18/2009 | 66VPL99MISCELLANEOUS PATENT MEDICINES, ETC. | New York District Office (NYK-DO) | |
| 4/9/2008 | 53LC99OTHER SKIN CARE PREPARATIONS, N.E.C. | 471CSTIC LBLG | New Orleans District Office (NOL-DO) |
| 10/31/2007 | 53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Seattle District Office (SEA-DO) |
| 3/1/2007 | 66VBJ99MISCELLANEOUS PATENT MEDICINES, ETC. | Baltimore District Office (BLT-DO) | |
| 3/6/2006 | 53JJ01BATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS) | 471CSTIC LBLG | Southwest Import District Office (SWI-DO) |
| 8/4/2004 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Southwest Import District Office (SWI-DO) |
| 10/14/2003 | 53JY01BATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS) | 473LABELING | Florida District Office (FLA-DO) |
| 10/14/2003 | 53LD03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 118NOT LISTED | Florida District Office (FLA-DO) |
Frequently Asked Questions
What is Ets Diana De Beaute's FDA import refusal history?
Ets Diana De Beaute (FEI: 3002054792) has 24 FDA import refusal record(s) in our database, spanning from 10/14/2003 to 9/15/2022.
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. Ets Diana De Beaute's FEI number is 3002054792.
What types of violations has Ets Diana De Beaute received?
Ets Diana De Beaute has been cited for 9 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 Ets Diana De Beaute come from?
All FDA import refusal data for Ets Diana 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.