L'Oreal Travel Retail Americas, Inc.
⚠️ Moderate Risk
FEI: 1000113698 • Miami, FL • UNITED STATES
FEI Number
1000113698
Location
Miami, FL
Country
UNITED STATESAddress
6100 Blue Lagoon Dr # S-200, , Miami, FL, 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
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).
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
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).
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.
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 3/28/2013 | 53CH03EYE SHADOW (EYE MAKEUP PREPARATIONS) | 197COSM COLOR | Division of Northeast Imports (DNEI) |
| 3/4/2013 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Southeast Imports (DSEI) | |
| 3/4/2013 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Southeast Imports (DSEI) | |
| 3/4/2013 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Southeast Imports (DSEI) | |
| 5/18/2011 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/18/2011 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/18/2011 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/18/2011 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/18/2011 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/18/2011 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 5/18/2011 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 10/5/2007 | 53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/3/2006 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 3/21/2006 | 53GC99OTHER MAKEUP PREPARATION, NOT FOR THE EYES, N.E.C. | 471CSTIC LBLG | Florida District Office (FLA-DO) |
| 12/29/2005 | 53AC02LOTIONS, OILS, POWDERS AND CREAMS (BABY PRODUCTS) | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 10/24/2003 | 53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 473LABELING | Florida District Office (FLA-DO) |
| 10/24/2003 | 53CH99OTHER EYE MAKEUP PREPARATIONS, N.E.C. | 473LABELING | Florida District Office (FLA-DO) |
Frequently Asked Questions
What is L'Oreal Travel Retail Americas, Inc.'s FDA import refusal history?
L'Oreal Travel Retail Americas, Inc. (FEI: 1000113698) has 17 FDA import refusal record(s) in our database, spanning from 10/24/2003 to 3/28/2013.
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. L'Oreal Travel Retail Americas, Inc.'s FEI number is 1000113698.
What types of violations has L'Oreal Travel Retail Americas, Inc. received?
L'Oreal Travel Retail Americas, Inc. has been cited for 6 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 Travel Retail Americas, Inc. come from?
All FDA import refusal data for L'Oreal Travel Retail Americas, Inc. 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.