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Taiwan Novelty (Hong Kong) Limited

✅ Low Risk

FEI: 1000264375 • Hung Hom, Kowloon • HONG KONG

FEI

FEI Number

1000264375

📍

Location

Hung Hom, Kowloon

🇭🇰

Country

HONG KONG
🏢

Address

Unit 505, Heng Ngai Jewelry Centre; 4 Hok Yuen Street East, Hung Hom, Kowloon, Hong Kong

Low Risk

FDA Import Risk Assessment

16.3
LowModerateHighCritical

This firm has a minimal history of FDA import refusals with low-severity violations.

Statistics

1
Total Refusals
1
Unique Violations
11/16/2005
Latest Refusal
11/16/2005
Earliest Refusal

Score Breakdown

Violation Severity
30.0×40%
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

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
11/16/2005
76EFWTOOTHBRUSH, MANUAL
341REGISTERED
Los Angeles District Office (LOS-DO)

Frequently Asked Questions

What is Taiwan Novelty (Hong Kong) Limited's FDA import refusal history?

Taiwan Novelty (Hong Kong) Limited (FEI: 1000264375) has 1 FDA import refusal record(s) in our database, spanning from 11/16/2005 to 11/16/2005.

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. Taiwan Novelty (Hong Kong) Limited's FEI number is 1000264375.

What types of violations has Taiwan Novelty (Hong Kong) Limited received?

Taiwan Novelty (Hong Kong) Limited 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 Taiwan Novelty (Hong Kong) Limited come from?

All FDA import refusal data for Taiwan Novelty (Hong Kong) Limited 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.