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Yiwu Huihao Beauty Supplies

⚠️ Moderate Risk

FEI: 3012038259 • Zhejiang • CHINA

FEI

FEI Number

3012038259

📍

Location

Zhejiang

🇨🇳

Country

CHINA
🏢

Address

No.2 Chunhan Dist, Yiwu, Zhejiang, , China

Moderate Risk

FDA Import Risk Assessment

32.3
LowModerateHighCritical

This firm has a moderate history of FDA import refusals. Some attention may be warranted.

Statistics

1
Total Refusals
1
Unique Violations
3/31/2016
Latest Refusal
3/31/2016
Earliest Refusal

Score Breakdown

Violation Severity
70.0×40%
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

5081×

NO 510(K)

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.

Refusal History

DateProductViolationsDivision
3/31/2016
79PAYOVER-THE-COUNTER RADIOFREQUENCY COAGULATION DEVICE FOR WRINKLE REDUCTION
508NO 510(K)
Division of West Coast Imports (DWCI)

Frequently Asked Questions

What is Yiwu Huihao Beauty Supplies's FDA import refusal history?

Yiwu Huihao Beauty Supplies (FEI: 3012038259) has 1 FDA import refusal record(s) in our database, spanning from 3/31/2016 to 3/31/2016.

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. Yiwu Huihao Beauty Supplies's FEI number is 3012038259.

What types of violations has Yiwu Huihao Beauty Supplies received?

Yiwu Huihao Beauty Supplies 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 Yiwu Huihao Beauty Supplies come from?

All FDA import refusal data for Yiwu Huihao Beauty Supplies 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.