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Modern Medical Equipment Manufacturing (Qing Yuan) Ltd.

⚠️ Moderate Risk

FEI: 3007421149 • Qing Yuan, Guangdong • CHINA

FEI

FEI Number

3007421149

📍

Location

Qing Yuan, Guangdong

🇨🇳

Country

CHINA
🏢

Address

GAO XIN JISHU INDUSTRIAL DEVELOPMENT DISTRICT, YING FU INDUSTRIAL AREA, Qing Yuan, Guangdong, China

Moderate Risk

FDA Import Risk Assessment

42.8
LowModerateHighCritical

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

Statistics

2
Total Refusals
1
Unique Violations
8/20/2025
Latest Refusal
4/9/2025
Earliest Refusal

Score Breakdown

Violation Severity
50.0×40%
Refusal Volume
17.7×30%
Recency
77.5×20%
Frequency
20.0×10%
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

32802×

FRNMFGREG

The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.

Refusal History

DateProductViolationsDivision
8/20/2025
79GEIDEVICE, ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
3280FRNMFGREG
Division of Northern Border Imports (DNBI)
4/9/2025
79GEIDEVICE, ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
3280FRNMFGREG
Division of Northern Border Imports (DNBI)

Frequently Asked Questions

What is Modern Medical Equipment Manufacturing (Qing Yuan) Ltd.'s FDA import refusal history?

Modern Medical Equipment Manufacturing (Qing Yuan) Ltd. (FEI: 3007421149) has 2 FDA import refusal record(s) in our database, spanning from 4/9/2025 to 8/20/2025.

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. Modern Medical Equipment Manufacturing (Qing Yuan) Ltd.'s FEI number is 3007421149.

What types of violations has Modern Medical Equipment Manufacturing (Qing Yuan) Ltd. received?

Modern Medical Equipment Manufacturing (Qing Yuan) 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 Modern Medical Equipment Manufacturing (Qing Yuan) Ltd. come from?

All FDA import refusal data for Modern Medical Equipment Manufacturing (Qing Yuan) 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.