ImportRefusal LogoImportRefusal

Yangzhou Huini Imp Exp Corp Ltd

✅ Low Risk

FEI: 3006981179 • Yangzhouyangzhou • CHINA

FEI

FEI Number

3006981179

📍

Location

Yangzhouyangzhou

🇨🇳

Country

CHINA
🏢

Address

Rm 401 Weiheng Mansion, , Yangzhouyangzhou, , China

Low Risk

FDA Import Risk Assessment

21.7
LowModerateHighCritical

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

Statistics

3
Total Refusals
1
Unique Violations
8/27/2008
Latest Refusal
8/27/2008
Earliest Refusal

Score Breakdown

Violation Severity
30.0×40%
Refusal Volume
22.3×30%
Recency
0.0×20%
Frequency
30.0×10%
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

3413×

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
8/27/2008
76MMDTOOTHBRUSH, IONIC, BATTERY-POWERED
341REGISTERED
Los Angeles District Office (LOS-DO)
8/27/2008
76MMDTOOTHBRUSH, IONIC, BATTERY-POWERED
341REGISTERED
Los Angeles District Office (LOS-DO)
8/27/2008
76MMDTOOTHBRUSH, IONIC, BATTERY-POWERED
341REGISTERED
Los Angeles District Office (LOS-DO)

Frequently Asked Questions

What is Yangzhou Huini Imp Exp Corp Ltd's FDA import refusal history?

Yangzhou Huini Imp Exp Corp Ltd (FEI: 3006981179) has 3 FDA import refusal record(s) in our database, spanning from 8/27/2008 to 8/27/2008.

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. Yangzhou Huini Imp Exp Corp Ltd's FEI number is 3006981179.

What types of violations has Yangzhou Huini Imp Exp Corp Ltd received?

Yangzhou Huini Imp Exp Corp 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 Yangzhou Huini Imp Exp Corp Ltd come from?

All FDA import refusal data for Yangzhou Huini Imp Exp Corp 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.