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Gold Edge Tech Co.

⚠️ High Risk

FEI: 3007596906 • Shenzhen • CHINA

FEI

FEI Number

3007596906

📍

Location

Shenzhen

🇨🇳

Country

CHINA
🏢

Address

501/A Xinbao Ind, , Shenzhen, , China

High Risk

FDA Import Risk Assessment

59.1
LowModerateHighCritical

This firm has a significant history of FDA import refusals with notable violations.

Statistics

14
Total Refusals
1
Unique Violations
7/9/2009
Latest Refusal
6/26/2009
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
Refusal Volume
43.6×30%
Recency
0.0×20%
Frequency
100.0×10%
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

7514×

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
7/9/2009
66BAQ44NICOTINE DELIVERY SYSTEM
75UNAPPROVED
Seattle District Office (SEA-DO)
7/9/2009
66BAQ44NICOTINE DELIVERY SYSTEM
75UNAPPROVED
Seattle District Office (SEA-DO)
7/9/2009
66BAQ44NICOTINE DELIVERY SYSTEM
75UNAPPROVED
Seattle District Office (SEA-DO)
7/9/2009
66BAQ44NICOTINE DELIVERY SYSTEM
75UNAPPROVED
Seattle District Office (SEA-DO)
7/9/2009
66BAQ44NICOTINE DELIVERY SYSTEM
75UNAPPROVED
Seattle District Office (SEA-DO)
7/9/2009
66BAQ44NICOTINE DELIVERY SYSTEM
75UNAPPROVED
Seattle District Office (SEA-DO)
7/9/2009
66BAQ44NICOTINE DELIVERY SYSTEM
75UNAPPROVED
Seattle District Office (SEA-DO)
7/9/2009
80MSNCIGARETTES (CONTAINING TOBACCO)
75UNAPPROVED
Seattle District Office (SEA-DO)
7/2/2009
66BAQ44NICOTINE DELIVERY SYSTEM
75UNAPPROVED
Seattle District Office (SEA-DO)
7/2/2009
66BAQ44NICOTINE DELIVERY SYSTEM
75UNAPPROVED
Seattle District Office (SEA-DO)
7/2/2009
66BAQ44NICOTINE DELIVERY SYSTEM
75UNAPPROVED
Seattle District Office (SEA-DO)
7/2/2009
66BAQ44NICOTINE DELIVERY SYSTEM
75UNAPPROVED
Seattle District Office (SEA-DO)
6/26/2009
66BAQ44NICOTINE DELIVERY SYSTEM
75UNAPPROVED
Seattle District Office (SEA-DO)
6/26/2009
66BAQ44NICOTINE DELIVERY SYSTEM
75UNAPPROVED
Seattle District Office (SEA-DO)

Frequently Asked Questions

What is Gold Edge Tech Co.'s FDA import refusal history?

Gold Edge Tech Co. (FEI: 3007596906) has 14 FDA import refusal record(s) in our database, spanning from 6/26/2009 to 7/9/2009.

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. Gold Edge Tech Co.'s FEI number is 3007596906.

What types of violations has Gold Edge Tech Co. received?

Gold Edge Tech Co. 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 Gold Edge Tech Co. come from?

All FDA import refusal data for Gold Edge Tech Co. 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.