Estee Lauder K.K.
⚠️ Moderate Risk
FEI: 3002409628 • Minato, Tokyo • JAPAN
FEI Number
3002409628
Location
Minato, Tokyo
Country
JAPANAddress
8 Chome 1-19, Akasaka, Minato, Tokyo, Japan
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
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).
FDF4APIGMP
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the methods and controls used in its manufacture and control do not appear to conform to current good manufacturing practices within the meaning of Section 501(a)(2)(B). This finished dosage form drug is made using an Active Pharmaceutical Ingredient from a facility that has been found non-compliant with current Good Manufacturing Practice (see Import Alert 66-40; http://www.accessdata.fda.gov/cms_ia/importalert_189.html). You may submit testimony to provide evidence to overcome the appearance of adulteration. The API source for this finished dosage form drug is:
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
Frequently Asked Questions
What is Estee Lauder K.K.'s FDA import refusal history?
Estee Lauder K.K. (FEI: 3002409628) has 2 FDA import refusal record(s) in our database, spanning from 2/26/2010 to 1/7/2016.
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 K.K.'s FEI number is 3002409628.
What types of violations has Estee Lauder K.K. received?
Estee Lauder K.K. has been cited for 3 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 K.K. come from?
All FDA import refusal data for Estee Lauder K.K. 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.