ImportRefusal LogoImportRefusal

LOREAL DEUTSCHLAND GMBH

⚠️ Moderate Risk

FEI: 3014735749 • Dusseldorf • GERMANY

FEI

FEI Number

3014735749

📍

Location

Dusseldorf

🇩🇪

Country

GERMANY
🏢

Address

Johannstrasse 1, , Dusseldorf, , Germany

Moderate Risk

FDA Import Risk Assessment

43.6
LowModerateHighCritical

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

Statistics

3
Total Refusals
5
Unique Violations
11/7/2024
Latest Refusal
12/14/2023
Earliest Refusal

Score Breakdown

Violation Severity
46.7×40%
Refusal Volume
22.3×30%
Recency
76.5×20%
Frequency
30.0×10%
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

1182×

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).

29401×

COSM MISB

The cosmetic's labeling appears to be false or misleading within the meaning of Section 201(n).

32001×

COSM MISB2

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears that its labeling is false or misleading in any particular.

38811×

COSMETFPLA

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to contain an undeclared color additive which renders it misbranded within the meaning of Sections 1454(c)(3)(B) and 1456 of the Fair Packaging and Labeling Act.

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.

Refusal History

DateProductViolationsDivision
11/7/2024
53CD02EYELINER (EYE MAKEUP PREPARATIONS)
2940COSM MISB
3200COSM MISB2
3881COSMETFPLA
471CSTIC LBLG
Division of Southeast Imports (DSEI)
12/14/2023
62WBQ17ALUMINUM CHLORIDE ASTRINGENT/ANTI-PERSPIRANT)
118NOT LISTED
Division of Northeast Imports (DNEI)
12/14/2023
62WBQ17ALUMINUM CHLORIDE ASTRINGENT/ANTI-PERSPIRANT)
118NOT LISTED
Division of Northeast Imports (DNEI)

Frequently Asked Questions

What is LOREAL DEUTSCHLAND GMBH's FDA import refusal history?

LOREAL DEUTSCHLAND GMBH (FEI: 3014735749) has 3 FDA import refusal record(s) in our database, spanning from 12/14/2023 to 11/7/2024.

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. LOREAL DEUTSCHLAND GMBH's FEI number is 3014735749.

What types of violations has LOREAL DEUTSCHLAND GMBH received?

LOREAL DEUTSCHLAND GMBH has been cited for 5 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 LOREAL DEUTSCHLAND GMBH come from?

All FDA import refusal data for LOREAL DEUTSCHLAND GMBH 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.