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Pros Int L Co Ltd

⚠️ Moderate Risk

FEI: 3005283337 • Seoulseoul • SOUTH KOREA

FEI

FEI Number

3005283337

📍

Location

Seoulseoul

🇰🇷
🏢

Address

345-21 Gasan Dong Kumchon Ku, , Seoulseoul, , South Korea

Moderate Risk

FDA Import Risk Assessment

32.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
11/10/2005
Latest Refusal
11/10/2005
Earliest Refusal

Score Breakdown

Violation Severity
70.0×40%
Refusal Volume
11.2×30%
Recency
0.0×20%
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

30811×

INVDEVICE

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a device for investigational use for which no exemption has been granted as prescribed by Section 520(g)

Refusal History

DateProductViolationsDivision
11/10/2005
79MVFSYSTEM, LASER, PHOTODYNAMIC THERAPY
3081INVDEVICE
Cincinnati District Office (CIN-DO)

Frequently Asked Questions

What is Pros Int L Co Ltd's FDA import refusal history?

Pros Int L Co Ltd (FEI: 3005283337) has 1 FDA import refusal record(s) in our database, spanning from 11/10/2005 to 11/10/2005.

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. Pros Int L Co Ltd's FEI number is 3005283337.

What types of violations has Pros Int L Co Ltd received?

Pros Int L Co Ltd 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 Pros Int L Co Ltd come from?

All FDA import refusal data for Pros Int L Co Ltd 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.