ImportRefusal LogoImportRefusal

YIWU HENGHAO HOUSEHOLD PRODUCTS

⚠️ Moderate Risk

FEI: 3016910039 • Yiwu City • CHINA

FEI

FEI Number

3016910039

📍

Location

Yiwu City

🇨🇳

Country

CHINA
🏢

Address

Fl 2, Block A No 308 Jin, Yiwu City, , 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
2
Unique Violations
8/10/2020
Latest Refusal
8/10/2020
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

4791×

DV QUALITY

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be adulterated since its strength differs from, or its purity or quality falls below, that which it purports or is represented to possess.

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
8/10/2020
73KHAMASK, SCAVENGING
479DV QUALITY
508NO 510(K)
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is YIWU HENGHAO HOUSEHOLD PRODUCTS's FDA import refusal history?

YIWU HENGHAO HOUSEHOLD PRODUCTS (FEI: 3016910039) has 1 FDA import refusal record(s) in our database, spanning from 8/10/2020 to 8/10/2020.

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 HENGHAO HOUSEHOLD PRODUCTS's FEI number is 3016910039.

What types of violations has YIWU HENGHAO HOUSEHOLD PRODUCTS received?

YIWU HENGHAO HOUSEHOLD PRODUCTS 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 YIWU HENGHAO HOUSEHOLD PRODUCTS come from?

All FDA import refusal data for YIWU HENGHAO HOUSEHOLD PRODUCTS 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.