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Tyx Technology (Hk) Co Ltd

⚠️ Moderate Risk

FEI: 3008495506 • Baoan • CHINA

FEI

FEI Number

3008495506

📍

Location

Baoan

🇨🇳

Country

CHINA
🏢

Address

Chao Hui Rd Longhua Town, , Baoan, , China

Moderate Risk

FDA Import Risk Assessment

43.3
LowModerateHighCritical

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

Statistics

2
Total Refusals
1
Unique Violations
11/9/2010
Latest Refusal
11/9/2010
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
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

752×

UNAPPROVED

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA).

Refusal History

DateProductViolationsDivision
11/9/2010
66BBY44NICOTINE DELIVERY SYSTEM
75UNAPPROVED
Seattle District Office (SEA-DO)
11/9/2010
66BBY44NICOTINE DELIVERY SYSTEM
75UNAPPROVED
Seattle District Office (SEA-DO)

Frequently Asked Questions

What is Tyx Technology (Hk) Co Ltd's FDA import refusal history?

Tyx Technology (Hk) Co Ltd (FEI: 3008495506) has 2 FDA import refusal record(s) in our database, spanning from 11/9/2010 to 11/9/2010.

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. Tyx Technology (Hk) Co Ltd's FEI number is 3008495506.

What types of violations has Tyx Technology (Hk) Co Ltd received?

Tyx Technology (Hk) 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 Tyx Technology (Hk) Co Ltd come from?

All FDA import refusal data for Tyx Technology (Hk) 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.