Estee Lauder Int'L
⚠️ High Risk
FEI: 1000192254 • London • UNITED KINGDOM
FEI Number
1000192254
Location
London
Country
UNITED KINGDOMAddress
65 Grosvenor Street, , London, , United Kingdom
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).
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 6/9/2017 | 53CC04EYE LOTION (EYE MAKEUP PREPARATIONS) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/9/2017 | 53CC04EYE LOTION (EYE MAKEUP PREPARATIONS) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/9/2017 | 53LD06MOISTURIZING (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/3/2017 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/3/2017 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/3/2017 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/15/2017 | 53LD06MOISTURIZING (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/15/2017 | 53LD07NIGHT (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/15/2017 | 53LD06MOISTURIZING (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/15/2017 | 53CC04EYE LOTION (EYE MAKEUP PREPARATIONS) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/15/2017 | 53CC04EYE LOTION (EYE MAKEUP PREPARATIONS) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/15/2017 | 53CC04EYE LOTION (EYE MAKEUP PREPARATIONS) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/23/2016 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 12/23/2016 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 6/23/2016 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 4/19/2016 | 53LD11ARGAN OIL | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 4/19/2016 | 66PBL99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 5/11/2010 | 62WBY17ALUMINUM CHLORIDE ASTRINGENT/ANTI-PERSPIRANT) | 118NOT LISTED | Florida District Office (FLA-DO) |
Frequently Asked Questions
What is Estee Lauder Int'L's FDA import refusal history?
Estee Lauder Int'L (FEI: 1000192254) has 18 FDA import refusal record(s) in our database, spanning from 5/11/2010 to 6/9/2017.
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 Int'L's FEI number is 1000192254.
What types of violations has Estee Lauder Int'L received?
Estee Lauder Int'L has been cited for 2 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 Int'L come from?
All FDA import refusal data for Estee Lauder Int'L 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.