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Hanmi Swiss Optical Co., Ltd.

⚠️ Moderate Risk

FEI: 3003047649 • Jung • SOUTH KOREA

FEI

FEI Number

3003047649

📍

Location

Jung

🇰🇷
🏢

Address

26-18 No, Daejon City, Ho-Dong, Jung, , South Korea

Moderate Risk

FDA Import Risk Assessment

28.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
6/26/2003
Latest Refusal
6/26/2003
Earliest Refusal

Score Breakdown

Violation Severity
60.0×40%
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

2351×

NOT IMPACT

The article appears to not have impact-resistant lenses in accordance with 21 CFR 801.410.

Refusal History

DateProductViolationsDivision
6/26/2003
86HQGLENS, SPECTACLE, NON-CUSTOM (PRESCRIPTION)
235NOT IMPACT
Cincinnati District Office (CIN-DO)

Frequently Asked Questions

What is Hanmi Swiss Optical Co., Ltd.'s FDA import refusal history?

Hanmi Swiss Optical Co., Ltd. (FEI: 3003047649) has 1 FDA import refusal record(s) in our database, spanning from 6/26/2003 to 6/26/2003.

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. Hanmi Swiss Optical Co., Ltd.'s FEI number is 3003047649.

What types of violations has Hanmi Swiss Optical Co., Ltd. received?

Hanmi Swiss Optical 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 Hanmi Swiss Optical Co., Ltd. come from?

All FDA import refusal data for Hanmi Swiss Optical 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.