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Cotronic Technology Ltd

⚠️ Moderate Risk

FEI: 3010028075 • Hong Kong • CHINA

FEI

FEI Number

3010028075

📍

Location

Hong Kong

🇨🇳

Country

CHINA
🏢

Address

43-47 Shan Mei St Fontan, , Hong Kong, , China

Moderate Risk

FDA Import Risk Assessment

32.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
11/22/2013
Latest Refusal
11/22/2013
Earliest Refusal

Score Breakdown

Violation Severity
70.0×40%
Refusal Volume
11.2×30%
Recency
0.0×20%
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

4791×

DV QUALITY

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be adulterated since its strength differs from, or its purity or quality falls below, that which it purports or is represented to possess.

Refusal History

DateProductViolationsDivision
11/22/2013
80FLLTHERMOMETER, ELECTRONIC, CLINICAL
479DV QUALITY
Detroit District Office (DET-DO)

Frequently Asked Questions

What is Cotronic Technology Ltd's FDA import refusal history?

Cotronic Technology Ltd (FEI: 3010028075) has 1 FDA import refusal record(s) in our database, spanning from 11/22/2013 to 11/22/2013.

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. Cotronic Technology Ltd's FEI number is 3010028075.

What types of violations has Cotronic Technology Ltd received?

Cotronic Technology 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 Cotronic Technology Ltd come from?

All FDA import refusal data for Cotronic Technology 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.