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Ningbo Fre Trade Zone Sunson Int'L

✅ Low Risk

FEI: 3003726071 • Ningbo, Zhejiang • CHINA

FEI

FEI Number

3003726071

📍

Location

Ningbo, Zhejiang

🇨🇳

Country

CHINA
🏢

Address

29 Dong Du Road, , Ningbo, Zhejiang, China

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
11/13/2002
Latest Refusal
11/13/2002
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
11/13/2002
76JEQTOOTHBRUSH, POWERED
341REGISTERED
Los Angeles District Office (LOS-DO)

Frequently Asked Questions

What is Ningbo Fre Trade Zone Sunson Int'L's FDA import refusal history?

Ningbo Fre Trade Zone Sunson Int'L (FEI: 3003726071) has 1 FDA import refusal record(s) in our database, spanning from 11/13/2002 to 11/13/2002.

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. Ningbo Fre Trade Zone Sunson Int'L's FEI number is 3003726071.

What types of violations has Ningbo Fre Trade Zone Sunson Int'L received?

Ningbo Fre Trade Zone Sunson Int'L 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 Ningbo Fre Trade Zone Sunson Int'L come from?

All FDA import refusal data for Ningbo Fre Trade Zone Sunson Int'L 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.