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Zhejiang Beauty and Health Electrical Appliance Co., Ltd.

⚠️ Moderate Risk

FEI: 3013077348 • Wenzhou, Zhejiang • CHINA

FEI

FEI Number

3013077348

📍

Location

Wenzhou, Zhejiang

🇨🇳

Country

CHINA
🏢

Address

339 19th Road, Binhai Economic And Technical Developmen, Wenzhou, Zhejiang, China

Moderate Risk

FDA Import Risk Assessment

26.0
LowModerateHighCritical

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

Statistics

4
Total Refusals
1
Unique Violations
4/30/2022
Latest Refusal
4/30/2022
Earliest Refusal

Score Breakdown

Violation Severity
30.0×40%
Refusal Volume
25.9×30%
Recency
11.2×20%
Frequency
40.0×10%
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

3414×

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
4/30/2022
79LWKRAZOR, SURGICAL
341REGISTERED
Division of West Coast Imports (DWCI)
4/30/2022
79LWKRAZOR, SURGICAL
341REGISTERED
Division of West Coast Imports (DWCI)
4/30/2022
79LWKRAZOR, SURGICAL
341REGISTERED
Division of West Coast Imports (DWCI)
4/30/2022
79LWKRAZOR, SURGICAL
341REGISTERED
Division of West Coast Imports (DWCI)

Frequently Asked Questions

What is Zhejiang Beauty and Health Electrical Appliance Co., Ltd.'s FDA import refusal history?

Zhejiang Beauty and Health Electrical Appliance Co., Ltd. (FEI: 3013077348) has 4 FDA import refusal record(s) in our database, spanning from 4/30/2022 to 4/30/2022.

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. Zhejiang Beauty and Health Electrical Appliance Co., Ltd.'s FEI number is 3013077348.

What types of violations has Zhejiang Beauty and Health Electrical Appliance Co., Ltd. received?

Zhejiang Beauty and Health Electrical Appliance Co., Ltd. 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 Zhejiang Beauty and Health Electrical Appliance Co., Ltd. come from?

All FDA import refusal data for Zhejiang Beauty and Health Electrical Appliance Co., Ltd. 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.