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Qing Dao Hualixing Trading Co.

✅ Low Risk

FEI: 3005198455 • Yiwu • CHINA

FEI

FEI Number

3005198455

📍

Location

Yiwu

🇨🇳

Country

CHINA
🏢

Address

No. 518 Zongze Road, , Yiwu, , 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
9/1/2005
Latest Refusal
9/1/2005
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
9/1/2005
89LYGMASSAGER, THERAPEUTIC, MANUAL
341REGISTERED
Florida District Office (FLA-DO)

Frequently Asked Questions

What is Qing Dao Hualixing Trading Co.'s FDA import refusal history?

Qing Dao Hualixing Trading Co. (FEI: 3005198455) has 1 FDA import refusal record(s) in our database, spanning from 9/1/2005 to 9/1/2005.

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. Qing Dao Hualixing Trading Co.'s FEI number is 3005198455.

What types of violations has Qing Dao Hualixing Trading Co. received?

Qing Dao Hualixing Trading 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 Qing Dao Hualixing Trading Co. come from?

All FDA import refusal data for Qing Dao Hualixing Trading 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.