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GARNIER COSMETICS

⚠️ Moderate Risk

FEI: 3015971892 • Paris, Paris • FRANCE

FEI

FEI Number

3015971892

📍

Location

Paris, Paris

🇫🇷

Country

FRANCE
🏢

Address

14 Rue Royale, , Paris, Paris, France

Moderate Risk

FDA Import Risk Assessment

38.0
LowModerateHighCritical

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

Statistics

1
Total Refusals
3
Unique Violations
6/12/2023
Latest Refusal
6/12/2023
Earliest Refusal

Score Breakdown

Violation Severity
60.0×40%
Refusal Volume
11.2×30%
Recency
48.3×20%
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

1181×

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).

30001×

N-RX INACT

The article appears to be a nonprescription drug and fails to bear the established name of each inactive ingredient in alphabetical order on the outside container of the retail package.

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
6/12/2023
66VAY99MISCELLANEOUS PATENT MEDICINES, ETC.
118NOT LISTED
3000N-RX INACT
75UNAPPROVED
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is GARNIER COSMETICS's FDA import refusal history?

GARNIER COSMETICS (FEI: 3015971892) has 1 FDA import refusal record(s) in our database, spanning from 6/12/2023 to 6/12/2023.

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. GARNIER COSMETICS's FEI number is 3015971892.

What types of violations has GARNIER COSMETICS received?

GARNIER COSMETICS 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 GARNIER COSMETICS come from?

All FDA import refusal data for GARNIER COSMETICS 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.