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Amperor Electronic (Shenzhen)

⚠️ Moderate Risk

FEI: 3007735045 • Shenzhen • CHINA

FEI

FEI Number

3007735045

📍

Location

Shenzhen

🇨🇳

Country

CHINA
🏢

Address

Nolsarfotau Bldg, , Shenzhen, , China

Moderate Risk

FDA Import Risk Assessment

35.3
LowModerateHighCritical

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

Statistics

2
Total Refusals
1
Unique Violations
5/3/2010
Latest Refusal
5/3/2010
Earliest Refusal

Score Breakdown

Violation Severity
70.0×40%
Refusal Volume
17.7×30%
Recency
0.0×20%
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

4792×

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
5/3/2010
80FLLTHERMOMETER, ELECTRONIC, CLINICAL
479DV QUALITY
New Orleans District Office (NOL-DO)
5/3/2010
80FLLTHERMOMETER, ELECTRONIC, CLINICAL
479DV QUALITY
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is Amperor Electronic (Shenzhen)'s FDA import refusal history?

Amperor Electronic (Shenzhen) (FEI: 3007735045) has 2 FDA import refusal record(s) in our database, spanning from 5/3/2010 to 5/3/2010.

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. Amperor Electronic (Shenzhen)'s FEI number is 3007735045.

What types of violations has Amperor Electronic (Shenzhen) received?

Amperor Electronic (Shenzhen) 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 Amperor Electronic (Shenzhen) come from?

All FDA import refusal data for Amperor Electronic (Shenzhen) 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.