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Sosen Usa Inc

⚠️ Moderate Risk

FEI: 3011911152 • Montreal, Quebec • CANADA

FEI

FEI Number

3011911152

📍

Location

Montreal, Quebec

🇨🇦

Country

CANADA
🏢

Address

1286 Mill St, , Montreal, Quebec, Canada

Moderate Risk

FDA Import Risk Assessment

47.7
LowModerateHighCritical

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

Statistics

4
Total Refusals
1
Unique Violations
11/20/2017
Latest Refusal
11/14/2016
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
Refusal Volume
25.9×30%
Recency
0.0×20%
Frequency
39.4×10%
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

754×

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
11/20/2017
53LC10WRINKLE SMOOTHING (SKIN CARE PREPARATIONS)
75UNAPPROVED
Division of Northern Border Imports (DNBI)
11/20/2017
53LC10WRINKLE SMOOTHING (SKIN CARE PREPARATIONS)
75UNAPPROVED
Division of Northern Border Imports (DNBI)
11/14/2016
53LD10WRINKLE SMOOTHING (SKIN CARE PREPARATIONS)
75UNAPPROVED
Division of Northern Border Imports (DNBI)
11/14/2016
53LC10WRINKLE SMOOTHING (SKIN CARE PREPARATIONS)
75UNAPPROVED
Division of Northern Border Imports (DNBI)

Frequently Asked Questions

What is Sosen Usa Inc's FDA import refusal history?

Sosen Usa Inc (FEI: 3011911152) has 4 FDA import refusal record(s) in our database, spanning from 11/14/2016 to 11/20/2017.

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. Sosen Usa Inc's FEI number is 3011911152.

What types of violations has Sosen Usa Inc received?

Sosen Usa Inc 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 Sosen Usa Inc come from?

All FDA import refusal data for Sosen Usa Inc 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.