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Yu Jie Health Thing Factory

✅ Low Risk

FEI: 3007945933 • Yiwu • CHINA

FEI

FEI Number

3007945933

📍

Location

Yiwu

🇨🇳

Country

CHINA
🏢

Address

Two Times Inh Districts 3f 26498 Store, , Yiwu, , China

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
11/17/2009
Latest Refusal
11/17/2009
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
11/17/2009
76EFWTOOTHBRUSH, MANUAL
118NOT LISTED
341REGISTERED
Florida District Office (FLA-DO)

Frequently Asked Questions

What is Yu Jie Health Thing Factory's FDA import refusal history?

Yu Jie Health Thing Factory (FEI: 3007945933) has 1 FDA import refusal record(s) in our database, spanning from 11/17/2009 to 11/17/2009.

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. Yu Jie Health Thing Factory's FEI number is 3007945933.

What types of violations has Yu Jie Health Thing Factory received?

Yu Jie Health Thing Factory 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 Yu Jie Health Thing Factory come from?

All FDA import refusal data for Yu Jie Health Thing Factory 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.