L'Oreal Usa, Inc.
⚠️ Moderate Risk
FEI: 3003763470 • Florence, KY • UNITED STATES
FEI Number
3003763470
Location
Florence, KY
Country
UNITED STATESAddress
7080 New Buffington Rd, , Florence, KY, 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
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.
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).
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.
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
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 |
|---|---|---|---|
| 10/30/2014 | 61HAL05ZINC PYRITHIONE (ANTI-BACTERIAL) | New York District Office (NYK-DO) | |
| 10/27/2014 | 61HDL05ZINC PYRITHIONE (ANTI-BACTERIAL) | Detroit District Office (DET-DO) | |
| 12/20/2004 | 53ED01HAIR CONDITIONERS (HAIR PREPARATIONS, NON-COLORING) | 471CSTIC LBLG | New York District Office (NYK-DO) |
| 12/20/2004 | 53ED06SHAMPOOS (HAIR PREPARATIONS, NON-COLORING) | 471CSTIC LBLG | New York District Office (NYK-DO) |
| 12/20/2004 | 53ED01HAIR CONDITIONERS (HAIR PREPARATIONS, NON-COLORING) | 471CSTIC LBLG | New York District Office (NYK-DO) |
| 12/20/2004 | 53ED06SHAMPOOS (HAIR PREPARATIONS, NON-COLORING) | 471CSTIC LBLG | New York District Office (NYK-DO) |
| 12/20/2004 | 53ED01HAIR CONDITIONERS (HAIR PREPARATIONS, NON-COLORING) | 471CSTIC LBLG | New York District Office (NYK-DO) |
| 12/20/2004 | 53ED06SHAMPOOS (HAIR PREPARATIONS, NON-COLORING) | 471CSTIC LBLG | New York District Office (NYK-DO) |
Frequently Asked Questions
What is L'Oreal Usa, Inc.'s FDA import refusal history?
L'Oreal Usa, Inc. (FEI: 3003763470) has 8 FDA import refusal record(s) in our database, spanning from 12/20/2004 to 10/30/2014.
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, Inc.'s FEI number is 3003763470.
What types of violations has L'Oreal Usa, Inc. received?
L'Oreal Usa, Inc. has been cited for 5 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, Inc. come from?
All FDA import refusal data for L'Oreal Usa, 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.