L'Oreal USA Dba Luxury Prod
⚠️ Moderate Risk
FEI: 3003618827 • Savannah, GA • UNITED STATES
FEI Number
3003618827
Location
Savannah, GA
Country
UNITED STATESAddress
141 Knowlton Way, , Savannah, GA, United States
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).
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 2/27/2015 | 65LBY11TITANIUM DIOXIDE (PROTECTANT) | New Orleans District Office (NOL-DO) | |
| 2/23/2012 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | New York District Office (NYK-DO) | |
| 2/23/2012 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | 118NOT LISTED | New York District Office (NYK-DO) |
| 7/8/2008 | 53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 475COSMETLBLG | New York District Office (NYK-DO) |
| 7/8/2008 | 53CC04EYE LOTION (EYE MAKEUP PREPARATIONS) | 475COSMETLBLG | New York District Office (NYK-DO) |
| 7/8/2008 | 53CC04EYE LOTION (EYE MAKEUP PREPARATIONS) | 475COSMETLBLG | New York District Office (NYK-DO) |
Frequently Asked Questions
What is L'Oreal USA Dba Luxury Prod's FDA import refusal history?
L'Oreal USA Dba Luxury Prod (FEI: 3003618827) has 6 FDA import refusal record(s) in our database, spanning from 7/8/2008 to 2/27/2015.
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. L'Oreal USA Dba Luxury Prod's FEI number is 3003618827.
What types of violations has L'Oreal USA Dba Luxury Prod received?
L'Oreal USA Dba Luxury Prod 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 L'Oreal USA Dba Luxury Prod come from?
All FDA import refusal data for L'Oreal USA Dba Luxury Prod 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.