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GUANGZHOU GD BEAUTY EQUIPMENT

⚠️ Moderate Risk

FEI: 3013644670 • Guangzhou, Guangdong • CHINA

FEI

FEI Number

3013644670

📍

Location

Guangzhou, Guangdong

🇨🇳

Country

CHINA
🏢

Address

Pengshang Industrial Areapengshang Zhifu Road, , Guangzhou, Guangdong, 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
9/27/2017
Latest Refusal
9/27/2017
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
9/27/2017
53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS)
508NO 510(K)
Division of Southwest Imports (DSWI)

Frequently Asked Questions

What is GUANGZHOU GD BEAUTY EQUIPMENT's FDA import refusal history?

GUANGZHOU GD BEAUTY EQUIPMENT (FEI: 3013644670) has 1 FDA import refusal record(s) in our database, spanning from 9/27/2017 to 9/27/2017.

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. GUANGZHOU GD BEAUTY EQUIPMENT's FEI number is 3013644670.

What types of violations has GUANGZHOU GD BEAUTY EQUIPMENT received?

GUANGZHOU GD BEAUTY EQUIPMENT 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 GUANGZHOU GD BEAUTY EQUIPMENT come from?

All FDA import refusal data for GUANGZHOU GD BEAUTY EQUIPMENT 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.