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GUANGZHOU RUIMEI TECHNOLOGY CO. LTD.

⚠️ Moderate Risk

FEI: 3008756272 • Guangzhou • CHINA

FEI

FEI Number

3008756272

📍

Location

Guangzhou

🇨🇳

Country

CHINA
🏢

Address

Hengsheng Building B, Huanshi Room 1019, No. 25 Zhong Road; Yuexiu District, Guangzhou, , China

Moderate Risk

FDA Import Risk Assessment

36.9
LowModerateHighCritical

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

Statistics

3
Total Refusals
1
Unique Violations
12/4/2012
Latest Refusal
7/25/2011
Earliest Refusal

Score Breakdown

Violation Severity
70.0×40%
Refusal Volume
22.3×30%
Recency
0.0×20%
Frequency
22.0×10%
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

5083×

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
12/4/2012
79GFEBRUSH, DERMABRASION
508NO 510(K)
Cincinnati District Office (CIN-DO)
7/25/2011
79GFEBRUSH, DERMABRASION
508NO 510(K)
Los Angeles District Office (LOS-DO)
7/25/2011
79GFEBRUSH, DERMABRASION
508NO 510(K)
Los Angeles District Office (LOS-DO)

Frequently Asked Questions

What is GUANGZHOU RUIMEI TECHNOLOGY CO. LTD.'s FDA import refusal history?

GUANGZHOU RUIMEI TECHNOLOGY CO. LTD. (FEI: 3008756272) has 3 FDA import refusal record(s) in our database, spanning from 7/25/2011 to 12/4/2012.

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 RUIMEI TECHNOLOGY CO. LTD.'s FEI number is 3008756272.

What types of violations has GUANGZHOU RUIMEI TECHNOLOGY CO. LTD. received?

GUANGZHOU RUIMEI TECHNOLOGY 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 GUANGZHOU RUIMEI TECHNOLOGY CO. LTD. come from?

All FDA import refusal data for GUANGZHOU RUIMEI TECHNOLOGY 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.