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JIANGSU MOLE ELECTRONIC TECHNOLOGY CO., LTD

⚠️ Moderate Risk

FEI: 3019530907 • Xuzhou, Jiangsu • CHINA

FEI

FEI Number

3019530907

📍

Location

Xuzhou, Jiangsu

🇨🇳

Country

CHINA
🏢

Address

Block A07, Quanshan Economic; Development District, Xuzhou, Jiangsu, China

Moderate Risk

FDA Import Risk Assessment

30.1
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
7/1/2024
Latest Refusal
7/1/2024
Earliest Refusal

Score Breakdown

Violation Severity
30.0×40%
Refusal Volume
11.2×30%
Recency
69.0×20%
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

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
7/1/2024
73CCWLARYNGOSCOPE, RIGID
341REGISTERED
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is JIANGSU MOLE ELECTRONIC TECHNOLOGY CO., LTD's FDA import refusal history?

JIANGSU MOLE ELECTRONIC TECHNOLOGY CO., LTD (FEI: 3019530907) has 1 FDA import refusal record(s) in our database, spanning from 7/1/2024 to 7/1/2024.

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. JIANGSU MOLE ELECTRONIC TECHNOLOGY CO., LTD's FEI number is 3019530907.

What types of violations has JIANGSU MOLE ELECTRONIC TECHNOLOGY CO., LTD received?

JIANGSU MOLE ELECTRONIC 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 JIANGSU MOLE ELECTRONIC TECHNOLOGY CO., LTD come from?

All FDA import refusal data for JIANGSU MOLE ELECTRONIC 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.