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Iei Technology Corp.

⚠️ Moderate Risk

FEI: 3009588711 • Shanghai • CHINA

FEI

FEI Number

3009588711

📍

Location

Shanghai

🇨🇳

Country

CHINA
🏢

Address

1f, No.515 Shenfu Rdxinzhuang Industrial, , Shanghai, , China

Moderate Risk

FDA Import Risk Assessment

28.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
12/15/2015
Latest Refusal
12/15/2015
Earliest Refusal

Score Breakdown

Violation Severity
60.0×40%
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

2231×

FALSE

The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose labeling appears to be false or misleading.

Refusal History

DateProductViolationsDivision
12/15/2015
74MWIMONITOR, PHYSIOLOGICAL, PATIENT (WITHOUT ARRHYTHMIA DETECTION OR ALARMS)
223FALSE
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is Iei Technology Corp.'s FDA import refusal history?

Iei Technology Corp. (FEI: 3009588711) has 1 FDA import refusal record(s) in our database, spanning from 12/15/2015 to 12/15/2015.

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. Iei Technology Corp.'s FEI number is 3009588711.

What types of violations has Iei Technology Corp. received?

Iei Technology Corp. 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 Iei Technology Corp. come from?

All FDA import refusal data for Iei Technology Corp. 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.