L'Oreal
⚠️ High Risk
FEI: 1000177551 • Paris, Paris • FRANCE
FEI Number
1000177551
Location
Paris, Paris
Country
FRANCEAddress
14 rue Royale, , Paris, Paris, France
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).
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.
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.
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).
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
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)).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/30/2025 | 53ED99OTHER HAIR PREPARATIONS, NON-COLORING), N.E.C. | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 12/4/2024 | 53LD03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | Division of Southeast Imports (DSEI) | |
| 9/24/2024 | 66PBJ99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | Division of Southeast Imports (DSEI) | |
| 5/22/2024 | 53EC99OTHER HAIR PREPARATIONS, NON-COLORING), N.E.C. | 471CSTIC LBLG | Division of Southeast Imports (DSEI) |
| 4/10/2024 | 53ED99OTHER HAIR PREPARATIONS, NON-COLORING), N.E.C. | 471CSTIC LBLG | Division of Southeast Imports (DSEI) |
| 10/5/2023 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 6/16/2023 | 53ED99OTHER HAIR PREPARATIONS, NON-COLORING), N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/6/2020 | 53EY99OTHER HAIR PREPARATIONS, NON-COLORING), N.E.C. | 75UNAPPROVED | Division of Northern Border Imports (DNBI) |
| 11/6/2020 | 53EY01HAIR CONDITIONERS (HAIR PREPARATIONS, NON-COLORING) | 75UNAPPROVED | Division of Northern Border Imports (DNBI) |
| 11/6/2020 | 53EY01HAIR CONDITIONERS (HAIR PREPARATIONS, NON-COLORING) | 75UNAPPROVED | Division of Northern Border Imports (DNBI) |
| 11/6/2020 | 53EY01HAIR CONDITIONERS (HAIR PREPARATIONS, NON-COLORING) | 75UNAPPROVED | Division of Northern Border Imports (DNBI) |
| 11/6/2020 | 53EY99OTHER HAIR PREPARATIONS, NON-COLORING), N.E.C. | 75UNAPPROVED | Division of Northern Border Imports (DNBI) |
| 10/15/2020 | 53EY99OTHER HAIR PREPARATIONS, NON-COLORING), N.E.C. | Division of Southeast Imports (DSEI) | |
| 11/27/2017 | 53ED01HAIR CONDITIONERS (HAIR PREPARATIONS, NON-COLORING) | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 11/27/2017 | 53ED07TONICS, DRESSINGS, AND OTHER HAIR GROOMING AIDS (HAIR PREPARATIONS, NON-COLORING) | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 11/27/2017 | 53ED01HAIR CONDITIONERS (HAIR PREPARATIONS, NON-COLORING) | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 4/19/2017 | 53LC08PASTE MASKS (MUD PACKS) (SKIN CARE PREPARATIONS) | Division of Southeast Imports (DSEI) | |
| 4/19/2017 | 53LC08PASTE MASKS (MUD PACKS) (SKIN CARE PREPARATIONS) | Division of Southeast Imports (DSEI) | |
| 8/9/2016 | 53EC99OTHER HAIR PREPARATIONS, NON-COLORING), N.E.C. | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 4/10/2006 | 54YIY99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 324NO ENGLISH | New Orleans District Office (NOL-DO) |
| 3/21/2006 | 53GC99OTHER MAKEUP PREPARATION, NOT FOR THE EYES, N.E.C. | 471CSTIC LBLG | 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) |
Frequently Asked Questions
What is L'Oreal's FDA import refusal history?
L'Oreal (FEI: 1000177551) has 22 FDA import refusal record(s) in our database, spanning from 3/21/2006 to 12/30/2025.
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's FEI number is 1000177551.
What types of violations has L'Oreal received?
L'Oreal has been cited for 7 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 come from?
All FDA import refusal data for L'Oreal 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.