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WEIFANG MINGLIANG ELECTRONICS CO

⚠️ Moderate Risk

FEI: 3029002343 • Weifang, Shandong • CHINA

FEI

FEI Number

3029002343

📍

Location

Weifang, Shandong

🇨🇳

Country

CHINA
🏢

Address

Bldg 15 Zhongnan High, Hanting, Weifang, Shandong, China

Moderate Risk

FDA Import Risk Assessment

35.4
LowModerateHighCritical

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

Statistics

1
Total Refusals
2
Unique Violations
10/16/2024
Latest Refusal
10/16/2024
Earliest Refusal

Score Breakdown

Violation Severity
40.0×40%
Refusal Volume
11.2×30%
Recency
75.3×20%
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

2881×

STD LABEL

The article appears to not bear labeling prescribed by the performance standard established under section 514.

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).

Refusal History

DateProductViolationsDivision
10/16/2024
79GEXPOWERED LASER SURGICAL INSTRUMENTS
288STD LABEL
341REGISTERED
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is WEIFANG MINGLIANG ELECTRONICS CO's FDA import refusal history?

WEIFANG MINGLIANG ELECTRONICS CO (FEI: 3029002343) has 1 FDA import refusal record(s) in our database, spanning from 10/16/2024 to 10/16/2024.

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. WEIFANG MINGLIANG ELECTRONICS CO's FEI number is 3029002343.

What types of violations has WEIFANG MINGLIANG ELECTRONICS CO received?

WEIFANG MINGLIANG ELECTRONICS CO 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 WEIFANG MINGLIANG ELECTRONICS CO come from?

All FDA import refusal data for WEIFANG MINGLIANG ELECTRONICS CO 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.