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Frame-Tec Co., Ltd

⚠️ Moderate Risk

FEI: 3005578671 • Daegu • SOUTH KOREA

FEI

FEI Number

3005578671

📍

Location

Daegu

🇰🇷
🏢

Address

622 Chimsan-Dong Buk-Gu, , Daegu, , South Korea

Moderate Risk

FDA Import Risk Assessment

39.0
LowModerateHighCritical

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

Statistics

7
Total Refusals
2
Unique Violations
10/16/2012
Latest Refusal
10/16/2012
Earliest Refusal

Score Breakdown

Violation Severity
55.0×40%
Refusal Volume
33.5×30%
Recency
0.0×20%
Frequency
70.0×10%
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

1187×

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).

2317×

LENS CERT

The lenses are declared by accompanying certificate to meet the requirements for impact-resistant lenses in 21 CFR 801.410 but does not appear to be impact-resistant.

Refusal History

DateProductViolationsDivision
10/16/2012
86HQZFRAME, SPECTACLE
118NOT LISTED
231LENS CERT
New York District Office (NYK-DO)
10/16/2012
86HQZFRAME, SPECTACLE
118NOT LISTED
231LENS CERT
New York District Office (NYK-DO)
10/16/2012
86HQZFRAME, SPECTACLE
118NOT LISTED
231LENS CERT
New York District Office (NYK-DO)
10/16/2012
86HQZFRAME, SPECTACLE
118NOT LISTED
231LENS CERT
New York District Office (NYK-DO)
10/16/2012
86HQZFRAME, SPECTACLE
118NOT LISTED
231LENS CERT
New York District Office (NYK-DO)
10/16/2012
86HQZFRAME, SPECTACLE
118NOT LISTED
231LENS CERT
New York District Office (NYK-DO)
10/16/2012
86HQZFRAME, SPECTACLE
118NOT LISTED
231LENS CERT
New York District Office (NYK-DO)

Frequently Asked Questions

What is Frame-Tec Co., Ltd's FDA import refusal history?

Frame-Tec Co., Ltd (FEI: 3005578671) has 7 FDA import refusal record(s) in our database, spanning from 10/16/2012 to 10/16/2012.

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. Frame-Tec Co., Ltd's FEI number is 3005578671.

What types of violations has Frame-Tec Co., Ltd received?

Frame-Tec 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 Frame-Tec Co., Ltd come from?

All FDA import refusal data for Frame-Tec 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.