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Migwang Contact Lens Co Ltd

⚠️ Moderate Risk

FEI: 3010007256 • Gyeongsan-si • SOUTH KOREA

FEI

FEI Number

3010007256

📍

Location

Gyeongsan-si

🇰🇷
🏢

Address

693 Namcheon-Ro Namcheon-Myeon, , Gyeongsan-si, , South Korea

Moderate Risk

FDA Import Risk Assessment

32.1
LowModerateHighCritical

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

Statistics

8
Total Refusals
2
Unique Violations
5/12/2016
Latest Refusal
2/19/2015
Earliest Refusal

Score Breakdown

Violation Severity
37.5×40%
Refusal Volume
35.3×30%
Recency
0.0×20%
Frequency
65.2×10%
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

4736×

LABELING

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

3412×

REGISTERED

It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).

Refusal History

DateProductViolationsDivision
5/12/2016
86LPLLENSES, SOFT CONTACT, DAILY WEAR
473LABELING
Atlanta District Office (ATL-DO)
5/12/2016
86LPLLENSES, SOFT CONTACT, DAILY WEAR
473LABELING
Atlanta District Office (ATL-DO)
5/12/2016
86LPLLENSES, SOFT CONTACT, DAILY WEAR
473LABELING
Atlanta District Office (ATL-DO)
5/12/2016
86LPLLENSES, SOFT CONTACT, DAILY WEAR
473LABELING
Atlanta District Office (ATL-DO)
5/12/2016
86LPLLENSES, SOFT CONTACT, DAILY WEAR
473LABELING
Atlanta District Office (ATL-DO)
5/12/2016
86LPLLENSES, SOFT CONTACT, DAILY WEAR
473LABELING
Atlanta District Office (ATL-DO)
2/19/2015
86MVNLENS, CONTACT (DISPOSABLE)
341REGISTERED
Division of Southeast Imports (DSEI)
2/19/2015
86MVNLENS, CONTACT (DISPOSABLE)
341REGISTERED
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is Migwang Contact Lens Co Ltd's FDA import refusal history?

Migwang Contact Lens Co Ltd (FEI: 3010007256) has 8 FDA import refusal record(s) in our database, spanning from 2/19/2015 to 5/12/2016.

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. Migwang Contact Lens Co Ltd's FEI number is 3010007256.

What types of violations has Migwang Contact Lens Co Ltd received?

Migwang Contact Lens Co Ltd has been cited for 2 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 Migwang Contact Lens Co Ltd come from?

All FDA import refusal data for Migwang Contact Lens 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.