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OLAE MADE IN FRANCE

⚠️ Moderate Risk

FEI: 3026466324 • Roquecourbe, Tarn • FRANCE

FEI

FEI Number

3026466324

📍

Location

Roquecourbe, Tarn

🇫🇷

Country

FRANCE
🏢

Address

421 Chemin Du Chateau De Lacalm, , Roquecourbe, Tarn, France

Moderate Risk

FDA Import Risk Assessment

40.0
LowModerateHighCritical

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

Statistics

1
Total Refusals
4
Unique Violations
6/10/2025
Latest Refusal
6/10/2025
Earliest Refusal

Score Breakdown

Violation Severity
45.0×40%
Refusal Volume
11.2×30%
Recency
88.3×20%
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

22801×

DIRSEXMPT

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a drug within the meaning of Section 201(g) and it lacks adequate directions for use.

4731×

LABELING

The article appears in violation of FPLA because of its placement, form and/or contents statement.

4741×

COSMETLBLG

It appears the label does not bear the common or usual name of the cosmetic.

4751×

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

DateProductViolationsDivision
6/10/2025
53LY99OTHER SKIN CARE PREPARATIONS, N.E.C.
2280DIRSEXMPT
473LABELING
474COSMETLBLG
475COSMETLBLG
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is OLAE MADE IN FRANCE's FDA import refusal history?

OLAE MADE IN FRANCE (FEI: 3026466324) has 1 FDA import refusal record(s) in our database, spanning from 6/10/2025 to 6/10/2025.

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. OLAE MADE IN FRANCE's FEI number is 3026466324.

What types of violations has OLAE MADE IN FRANCE received?

OLAE MADE IN FRANCE has been cited for 4 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 OLAE MADE IN FRANCE come from?

All FDA import refusal data for OLAE MADE IN FRANCE 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.