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Yih Jiang Enterprise Co Ltd

✅ Low Risk

FEI: 3003828880 • Kaohsiung • TAIWAN

FEI

FEI Number

3003828880

📍

Location

Kaohsiung

🇹🇼

Country

TAIWAN
🏢

Address

1f 192 Ho Ping 2nd Road, , Kaohsiung, , Taiwan

Low Risk

FDA Import Risk Assessment

20.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
2
Unique Violations
1/7/2003
Latest Refusal
1/7/2003
Earliest Refusal

Score Breakdown

Violation Severity
40.0×40%
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).

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
1/7/2003
80FMFSYRINGE, PISTON
118NOT LISTED
341REGISTERED
Cincinnati District Office (CIN-DO)

Frequently Asked Questions

What is Yih Jiang Enterprise Co Ltd's FDA import refusal history?

Yih Jiang Enterprise Co Ltd (FEI: 3003828880) has 1 FDA import refusal record(s) in our database, spanning from 1/7/2003 to 1/7/2003.

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. Yih Jiang Enterprise Co Ltd's FEI number is 3003828880.

What types of violations has Yih Jiang Enterprise Co Ltd received?

Yih Jiang Enterprise 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 Yih Jiang Enterprise Co Ltd come from?

All FDA import refusal data for Yih Jiang 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.