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Estee Lauder Canada Cosmetics Ltd.

⚠️ Moderate Risk

FEI: 3005694449 • Ottawa, ONTARIO • CANADA

FEI

FEI Number

3005694449

📍

Location

Ottawa, ONTARIO

🇨🇦

Country

CANADA
🏢

Address

P.O. Box 26012, , Ottawa, ONTARIO, Canada

Moderate Risk

FDA Import Risk Assessment

35.4
LowModerateHighCritical

This firm has a moderate history of FDA import refusals. Some attention may be warranted.

Statistics

6
Total Refusals
1
Unique Violations
4/2/2014
Latest Refusal
4/2/2014
Earliest Refusal

Score Breakdown

Violation Severity
50.0×40%
Refusal Volume
31.3×30%
Recency
0.0×20%
Frequency
60.0×10%
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

1186×

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

DateProductViolationsDivision
4/2/2014
66PBL99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C.
118NOT LISTED
Division of Northeast Imports (DNEI)
4/2/2014
66PBL99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C.
118NOT LISTED
Division of Northeast Imports (DNEI)
4/2/2014
66PBL99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C.
118NOT LISTED
Division of Northeast Imports (DNEI)
4/2/2014
66PBL07OXYBENZONE (ULTRAVIOLET SCREEN/SUNSCREEN)
118NOT LISTED
Division of Northeast Imports (DNEI)
4/2/2014
66PBL99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C.
118NOT LISTED
Division of Northeast Imports (DNEI)
4/2/2014
66PBL99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C.
118NOT LISTED
Division of Northeast Imports (DNEI)

Frequently Asked Questions

What is Estee Lauder Canada Cosmetics Ltd.'s FDA import refusal history?

Estee Lauder Canada Cosmetics Ltd. (FEI: 3005694449) has 6 FDA import refusal record(s) in our database, spanning from 4/2/2014 to 4/2/2014.

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. Estee Lauder Canada Cosmetics Ltd.'s FEI number is 3005694449.

What types of violations has Estee Lauder Canada Cosmetics Ltd. received?

Estee Lauder Canada Cosmetics Ltd. has been cited for 1 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 Canada Cosmetics Ltd. come from?

All FDA import refusal data for Estee Lauder Canada Cosmetics Ltd. 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.