ImportRefusal LogoImportRefusal

MAXEY COSMETICS OU

⚠️ Moderate Risk

FEI: 3015221852 • Tallinn, Harju • ESTONIA

FEI

FEI Number

3015221852

📍

Location

Tallinn, Harju

🇪🇪

Country

ESTONIA
🏢

Address

Teaduspargi 3/1, , Tallinn, Harju, Estonia

Moderate Risk

FDA Import Risk Assessment

30.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
2
Unique Violations
4/9/2019
Latest Refusal
4/9/2019
Earliest Refusal

Score Breakdown

Violation Severity
65.0×40%
Refusal Volume
11.2×30%
Recency
0.0×20%
Frequency
10.0×10%
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

4711×

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.

751×

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).

Refusal History

DateProductViolationsDivision
4/9/2019
53CF99OTHER EYE MAKEUP PREPARATIONS, N.E.C.
471CSTIC LBLG
75UNAPPROVED
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is MAXEY COSMETICS OU's FDA import refusal history?

MAXEY COSMETICS OU (FEI: 3015221852) has 1 FDA import refusal record(s) in our database, spanning from 4/9/2019 to 4/9/2019.

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. MAXEY COSMETICS OU's FEI number is 3015221852.

What types of violations has MAXEY COSMETICS OU received?

MAXEY COSMETICS OU 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 MAXEY COSMETICS OU come from?

All FDA import refusal data for MAXEY COSMETICS OU 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.