Estee Lauder Cosmetics, Ltd. (Alden Manufacturing)
⚠️ Moderate Risk
FEI: 1000445672 • Markham, Ontario • CANADA
FEI Number
1000445672
Location
Markham, Ontario
Country
CANADAAddress
100 Alden Rd, , Markham, Ontario, Canada
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.
COSM COLOR
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to contain a color additive which is unsafe within the meaning of Section 721(a) which renders it adulterated under Section 601(e).
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 10/8/2015 | 53CH03EYE SHADOW (EYE MAKEUP PREPARATIONS) | New York District Office (NYK-DO) | |
| 10/8/2015 | 53CH03EYE SHADOW (EYE MAKEUP PREPARATIONS) | New York District Office (NYK-DO) | |
| 2/2/2012 | 53GD04LEG AND BODY PAINTS (MAKEUP PREPARATIONS, NOT FOR EYES) | New York District Office (NYK-DO) | |
| 2/2/2012 | 53GD04LEG AND BODY PAINTS (MAKEUP PREPARATIONS, NOT FOR EYES) | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Estee Lauder Cosmetics, Ltd. (Alden Manufacturing)'s FDA import refusal history?
Estee Lauder Cosmetics, Ltd. (Alden Manufacturing) (FEI: 1000445672) has 4 FDA import refusal record(s) in our database, spanning from 2/2/2012 to 10/8/2015.
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 Cosmetics, Ltd. (Alden Manufacturing)'s FEI number is 1000445672.
What types of violations has Estee Lauder Cosmetics, Ltd. (Alden Manufacturing) received?
Estee Lauder Cosmetics, Ltd. (Alden Manufacturing) 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 Cosmetics, Ltd. (Alden Manufacturing) come from?
All FDA import refusal data for Estee Lauder Cosmetics, Ltd. (Alden Manufacturing) 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.