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Focus Systems Technology Co. Ltd

✅ Low Risk

FEI: 3004434029 • Taipei • TAIWAN

FEI

FEI Number

3004434029

📍

Location

Taipei

🇹🇼

Country

TAIWAN
🏢

Address

3f, No.24, Chung Cheng St., , Taipei, , Taiwan

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
8/30/2013
Latest Refusal
8/30/2013
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
8/30/2013
86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)
118NOT LISTED
Chicago District Office (CHI-DO)

Frequently Asked Questions

What is Focus Systems Technology Co. Ltd's FDA import refusal history?

Focus Systems Technology Co. Ltd (FEI: 3004434029) has 1 FDA import refusal record(s) in our database, spanning from 8/30/2013 to 8/30/2013.

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. Focus Systems Technology Co. Ltd's FEI number is 3004434029.

What types of violations has Focus Systems Technology Co. Ltd received?

Focus Systems Technology 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 Focus Systems Technology Co. Ltd come from?

All FDA import refusal data for Focus Systems Technology 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.