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Norte Sirius Enterprise Co Ltd

⚠️ Moderate Risk

FEI: 3010136050 • New Taipei City • TAIWAN

FEI

FEI Number

3010136050

📍

Location

New Taipei City

🇹🇼

Country

TAIWAN
🏢

Address

10 195-1 Shin-Sheng Stchung-Ho District, , New Taipei City, , Taiwan

Moderate Risk

FDA Import Risk Assessment

25.9
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
6/12/2023
Latest Refusal
6/12/2023
Earliest Refusal

Score Breakdown

Violation Severity
30.0×40%
Refusal Volume
11.2×30%
Recency
47.7×20%
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
6/12/2023
89ISAMASSAGER, THERAPEUTIC, ELECTRIC
341REGISTERED
Division of West Coast Imports (DWCI)

Frequently Asked Questions

What is Norte Sirius Enterprise Co Ltd's FDA import refusal history?

Norte Sirius Enterprise Co Ltd (FEI: 3010136050) has 1 FDA import refusal record(s) in our database, spanning from 6/12/2023 to 6/12/2023.

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. Norte Sirius Enterprise Co Ltd's FEI number is 3010136050.

What types of violations has Norte Sirius Enterprise Co Ltd received?

Norte Sirius Enterprise 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 Norte Sirius Enterprise Co Ltd come from?

All FDA import refusal data for Norte Sirius Enterprise 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.