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Zyfas, Samchundang Pharm Co Ltd

✅ Low Risk

FEI: 3005573823 • Seoul • SOUTH KOREA

FEI

FEI Number

3005573823

📍

Location

Seoul

🇰🇷
🏢

Address

Unknown Street, , Seoul, , South Korea

Low Risk

FDA Import Risk Assessment

24.3
LowModerateHighCritical

This firm has a minimal history of FDA import refusals with low-severity violations.

Statistics

1
Total Refusals
1
Unique Violations
3/1/2006
Latest Refusal
3/1/2006
Earliest Refusal

Score Breakdown

Violation Severity
50.0×40%
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

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).

Refusal History

DateProductViolationsDivision
3/1/2006
61FDB61GATIFLOXACIN (ANTI-BACTERIAL PART I) (NOT ANTIBIOTIC)
118NOT LISTED
San Francisco District Office (SAN-DO)

Frequently Asked Questions

What is Zyfas, Samchundang Pharm Co Ltd's FDA import refusal history?

Zyfas, Samchundang Pharm Co Ltd (FEI: 3005573823) has 1 FDA import refusal record(s) in our database, spanning from 3/1/2006 to 3/1/2006.

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. Zyfas, Samchundang Pharm Co Ltd's FEI number is 3005573823.

What types of violations has Zyfas, Samchundang Pharm Co Ltd received?

Zyfas, Samchundang Pharm 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 Zyfas, Samchundang Pharm Co Ltd come from?

All FDA import refusal data for Zyfas, Samchundang Pharm 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.