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GUANGZHOU YINGCAI BEAUTY INSTRUMENT CO., LTD.

⚠️ Moderate Risk

FEI: 3023876597 • Guangzhou, Guangdong • CHINA

FEI

FEI Number

3023876597

📍

Location

Guangzhou, Guangdong

🇨🇳

Country

CHINA
🏢

Address

6th Floor, No. 7 Yinbian 1st Street; Dongshan, Guangzhou, Guangdong, China

Moderate Risk

FDA Import Risk Assessment

39.0
LowModerateHighCritical

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

Statistics

1
Total Refusals
2
Unique Violations
6/6/2025
Latest Refusal
6/6/2025
Earliest Refusal

Score Breakdown

Violation Severity
50.0×40%
Refusal Volume
11.2×30%
Recency
73.1×20%
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).

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
6/6/2025
79OUPPOWERED SURGICAL INSTRUMENTS FOR IMPROVEMENT IN THE APPEARANCE OF CELLULITE
341REGISTERED
508NO 510(K)
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is GUANGZHOU YINGCAI BEAUTY INSTRUMENT CO., LTD.'s FDA import refusal history?

GUANGZHOU YINGCAI BEAUTY INSTRUMENT CO., LTD. (FEI: 3023876597) has 1 FDA import refusal record(s) in our database, spanning from 6/6/2025 to 6/6/2025.

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 YINGCAI BEAUTY INSTRUMENT CO., LTD.'s FEI number is 3023876597.

What types of violations has GUANGZHOU YINGCAI BEAUTY INSTRUMENT CO., LTD. received?

GUANGZHOU YINGCAI BEAUTY INSTRUMENT CO., LTD. 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 GUANGZHOU YINGCAI BEAUTY INSTRUMENT CO., LTD. come from?

All FDA import refusal data for GUANGZHOU YINGCAI BEAUTY INSTRUMENT 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.