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Shenzhen GCORE Technology Co., Ltd.

⚠️ High Risk

FEI: 3030373389 • Shenzhen, Guangdong • CHINA

FEI

FEI Number

3030373389

📍

Location

Shenzhen, Guangdong

🇨🇳

Country

CHINA
🏢

Address

201, Building B, Yabian Xueziwei Industrial Park, Yabian Community, Shajing Street, , Shenzhen, Guangdong, China

High Risk

FDA Import Risk Assessment

59.6
LowModerateHighCritical

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

Statistics

15
Total Refusals
2
Unique Violations
2/6/2024
Latest Refusal
2/6/2024
Earliest Refusal

Score Breakdown

Violation Severity
60.0×40%
Refusal Volume
44.6×30%
Recency
60.9×20%
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

384215×

TP NO PMTA

This article is subject to refusal of admission pursuant to section 801(a)(3) of the FD&C Act because it is a tobacco product that FDA has found to be adulterated under section 902(6)(A) of the FD&C Act in that it does not have an FDA marketing order in effect under section 910(c)(1)(A)(i) of the FD&C Act.

384315×

TP NO SE

This article is subject to refusal of admission pursuant to section 801(a)(3) of the FD&C Act because it is a tobacco product that FDA has found to be misbranded under section 903(a)(6) of the FD&C Act in that a notice or other information respecting it was not provided as required by section 905(j).

Refusal History

DateProductViolationsDivision
2/6/2024
98LCA99ELECTRONIC NICOTINE DELIVERY SYSTEM, NEC
3842TP NO PMTA
3843TP NO SE
Division of West Coast Imports (DWCI)
2/6/2024
98LCA99ELECTRONIC NICOTINE DELIVERY SYSTEM, NEC
3842TP NO PMTA
3843TP NO SE
Division of West Coast Imports (DWCI)
2/6/2024
98LCA99ELECTRONIC NICOTINE DELIVERY SYSTEM, NEC
3842TP NO PMTA
3843TP NO SE
Division of West Coast Imports (DWCI)
2/6/2024
98LCA99ELECTRONIC NICOTINE DELIVERY SYSTEM, NEC
3842TP NO PMTA
3843TP NO SE
Division of West Coast Imports (DWCI)
2/6/2024
98LCA99ELECTRONIC NICOTINE DELIVERY SYSTEM, NEC
3842TP NO PMTA
3843TP NO SE
Division of West Coast Imports (DWCI)
2/6/2024
98LCA99ELECTRONIC NICOTINE DELIVERY SYSTEM, NEC
3842TP NO PMTA
3843TP NO SE
Division of West Coast Imports (DWCI)
2/6/2024
98LCA99ELECTRONIC NICOTINE DELIVERY SYSTEM, NEC
3842TP NO PMTA
3843TP NO SE
Division of West Coast Imports (DWCI)
2/6/2024
98LCA99ELECTRONIC NICOTINE DELIVERY SYSTEM, NEC
3842TP NO PMTA
3843TP NO SE
Division of West Coast Imports (DWCI)
2/6/2024
98LCA99ELECTRONIC NICOTINE DELIVERY SYSTEM, NEC
3842TP NO PMTA
3843TP NO SE
Division of West Coast Imports (DWCI)
2/6/2024
98LCA99ELECTRONIC NICOTINE DELIVERY SYSTEM, NEC
3842TP NO PMTA
3843TP NO SE
Division of West Coast Imports (DWCI)
2/6/2024
98LCA99ELECTRONIC NICOTINE DELIVERY SYSTEM, NEC
3842TP NO PMTA
3843TP NO SE
Division of West Coast Imports (DWCI)
2/6/2024
98LCA99ELECTRONIC NICOTINE DELIVERY SYSTEM, NEC
3842TP NO PMTA
3843TP NO SE
Division of West Coast Imports (DWCI)
2/6/2024
98LCA99ELECTRONIC NICOTINE DELIVERY SYSTEM, NEC
3842TP NO PMTA
3843TP NO SE
Division of West Coast Imports (DWCI)
2/6/2024
98LCA99ELECTRONIC NICOTINE DELIVERY SYSTEM, NEC
3842TP NO PMTA
3843TP NO SE
Division of West Coast Imports (DWCI)
2/6/2024
98LCA99ELECTRONIC NICOTINE DELIVERY SYSTEM, NEC
3842TP NO PMTA
3843TP NO SE
Division of West Coast Imports (DWCI)

Frequently Asked Questions

What is Shenzhen GCORE Technology Co., Ltd.'s FDA import refusal history?

Shenzhen GCORE Technology Co., Ltd. (FEI: 3030373389) has 15 FDA import refusal record(s) in our database, spanning from 2/6/2024 to 2/6/2024.

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. Shenzhen GCORE Technology Co., Ltd.'s FEI number is 3030373389.

What types of violations has Shenzhen GCORE Technology Co., Ltd. received?

Shenzhen GCORE Technology Co., Ltd. has been cited for 2 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 Shenzhen GCORE Technology Co., Ltd. come from?

All FDA import refusal data for Shenzhen GCORE Technology 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.