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Sun Probe Enterprise Co Ltd

✅ Low Risk

FEI: 3005868318 • Yung Kang Tainen • TAIWAN

FEI

FEI Number

3005868318

📍

Location

Yung Kang Tainen

🇹🇼

Country

TAIWAN
🏢

Address

83 Ln 520 Cheng Nan 5 St, , Yung Kang Tainen, , Taiwan

Low Risk

FDA Import Risk Assessment

16.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
11/15/2012
Latest Refusal
11/15/2012
Earliest Refusal

Score Breakdown

Violation Severity
30.0×40%
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

3411×

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
11/15/2012
86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)
341REGISTERED
Detroit District Office (DET-DO)

Frequently Asked Questions

What is Sun Probe Enterprise Co Ltd's FDA import refusal history?

Sun Probe Enterprise Co Ltd (FEI: 3005868318) has 1 FDA import refusal record(s) in our database, spanning from 11/15/2012 to 11/15/2012.

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. Sun Probe Enterprise Co Ltd's FEI number is 3005868318.

What types of violations has Sun Probe Enterprise Co Ltd received?

Sun Probe Enterprise 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 Sun Probe Enterprise Co Ltd come from?

All FDA import refusal data for Sun Probe Enterprise 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.