Estee Lauder Inc
⚠️ Moderate Risk
FEI: 2480525 • New York, NY • UNITED STATES
FEI Number
2480525
Location
New York, NY
Country
UNITED STATESAddress
767 5th Ave Fl 47th, , New York, NY, 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.
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).
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.
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 9/2/2020 | 66PBL99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | Division of Northern Border Imports (DNBI) | |
| 9/2/2020 | 66PBL99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | Division of Northern Border Imports (DNBI) | |
| 9/2/2020 | 66PBL99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | Division of Northern Border Imports (DNBI) | |
| 12/26/2019 | 66PBJ99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 9/17/2018 | 66PBL99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | Division of Southeast Imports (DSEI) | |
| 9/17/2018 | 66PBL99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | Division of Southeast Imports (DSEI) | |
| 6/7/2012 | 53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 473LABELING | San Juan District Office (SJN-DO) |
| 6/7/2012 | 53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 473LABELING | San Juan District Office (SJN-DO) |
| 6/7/2012 | 53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 473LABELING | San Juan District Office (SJN-DO) |
| 2/26/2010 | 53DA01COLOGNES AND TOILET WATERS (FRAGRANCE PREPARATIONS) | 471CSTIC LBLG | Division of Southeast Imports (DSEI) |
| 2/26/2010 | 53DA01COLOGNES AND TOILET WATERS (FRAGRANCE PREPARATIONS) | 471CSTIC LBLG | Division of Southeast Imports (DSEI) |
| 2/26/2010 | 53DA02PERFUMES (FRAGRANCE PREPARATIONS) | 471CSTIC LBLG | Division of Southeast Imports (DSEI) |
| 12/1/2006 | 53MC99OTHER SUNTAN PREPARATIONS (NOT SUNSCREEN), N.E.C. | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 12/1/2006 | 53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 12/1/2006 | 53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 12/1/2006 | 53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 12/1/2006 | 53YD99OTHER COSMETIC AND COSMETIC PRODUCTS, N.E.C. | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 10/18/2006 | 66PBL07OXYBENZONE (ULTRAVIOLET SCREEN/SUNSCREEN) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 10/18/2006 | 66PBL07OXYBENZONE (ULTRAVIOLET SCREEN/SUNSCREEN) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 10/18/2006 | 66PBL07OXYBENZONE (ULTRAVIOLET SCREEN/SUNSCREEN) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 5/13/2002 | 53CI04EYE LOTION (EYE MAKEUP PREPARATIONS) | 118NOT LISTED | Florida District Office (FLA-DO) |
| 10/23/2001 | 53LD01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS) | 471CSTIC LBLG | Florida District Office (FLA-DO) |
| 10/23/2001 | 53CG06MASCARA (EYE MAKEUP PREPARATIONS) | 471CSTIC LBLG | Florida District Office (FLA-DO) |
| 10/23/2001 | 53LD01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS) | 471CSTIC LBLG | Florida District Office (FLA-DO) |
| 10/23/2001 | 53LD01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS) | 471CSTIC LBLG | Florida District Office (FLA-DO) |
| 10/23/2001 | 53LD01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS) | 471CSTIC LBLG | Florida District Office (FLA-DO) |
| 10/23/2001 | 53CG06MASCARA (EYE MAKEUP PREPARATIONS) | 471CSTIC LBLG | Florida District Office (FLA-DO) |
Frequently Asked Questions
What is Estee Lauder Inc's FDA import refusal history?
Estee Lauder Inc (FEI: 2480525) has 27 FDA import refusal record(s) in our database, spanning from 10/23/2001 to 9/2/2020.
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. Estee Lauder Inc's FEI number is 2480525.
What types of violations has Estee Lauder Inc received?
Estee Lauder 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 Estee Lauder Inc come from?
All FDA import refusal data for Estee Lauder 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.