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Song Young International Co.

✅ Low Risk

FEI: 3000302881 • Taipei • TAIWAN

FEI

FEI Number

3000302881

📍

Location

Taipei

🇹🇼

Country

TAIWAN
🏢

Address

F/2-1, No. 376, Sec. 1,, Tun Hwa South Road, 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
12/10/2015
Latest Refusal
12/10/2015
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
12/10/2015
80FLGCLEANER, ULTRASONIC, MEDICAL INSTRUMENT
118NOT LISTED
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is Song Young International Co.'s FDA import refusal history?

Song Young International Co. (FEI: 3000302881) has 1 FDA import refusal record(s) in our database, spanning from 12/10/2015 to 12/10/2015.

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. Song Young International Co.'s FEI number is 3000302881.

What types of violations has Song Young International Co. received?

Song Young International Co. 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 Song Young International Co. come from?

All FDA import refusal data for Song Young International Co. 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.