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Sofamo

⚠️ Moderate Risk

FEI: 3008749488 • Monaco • MONACO

FEI

FEI Number

3008749488

📍

Location

Monaco

🇲🇨

Country

MONACO
🏢

Address

11 Avenue Albert Ii, , Monaco, , Monaco

Moderate Risk

FDA Import Risk Assessment

45.7
LowModerateHighCritical

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

Statistics

3
Total Refusals
1
Unique Violations
7/28/2011
Latest Refusal
7/28/2011
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
Refusal Volume
22.3×30%
Recency
0.0×20%
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

1973×

COSM COLOR

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to contain a color additive which is unsafe within the meaning of Section 721(a) which renders it adulterated under Section 601(e).

Refusal History

DateProductViolationsDivision
7/28/2011
53LD06MOISTURIZING (SKIN CARE PREPARATIONS)
197COSM COLOR
Florida District Office (FLA-DO)
7/28/2011
53LD06MOISTURIZING (SKIN CARE PREPARATIONS)
197COSM COLOR
Florida District Office (FLA-DO)
7/28/2011
53LD06MOISTURIZING (SKIN CARE PREPARATIONS)
197COSM COLOR
Florida District Office (FLA-DO)

Frequently Asked Questions

What is Sofamo's FDA import refusal history?

Sofamo (FEI: 3008749488) has 3 FDA import refusal record(s) in our database, spanning from 7/28/2011 to 7/28/2011.

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. Sofamo's FEI number is 3008749488.

What types of violations has Sofamo received?

Sofamo 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 Sofamo come from?

All FDA import refusal data for Sofamo 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.