Shenzhen SKE Technology co., Ltd
⚠️ High Risk
FEI: 3031468591 • Shenzhen • CHINA
FEI Number
3031468591
Location
Shenzhen
Country
CHINAAddress
Building 3, Antuoshan Hi-Tech Industrial Park,, Shajing Street, Bao'an District, Shenzhen, , China
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable violations.
Statistics
Score Breakdown
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
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.
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).
TPLKUSSLLB
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act because it is a tobacco product in package form that appears to be misbranded under section 903(a)(2)(D) of the FD&C Act in that the label does not provide the statement "sale only allowed in the United States" and the tobacco product is not subject to any exemptions or variations.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/1/2025 | 98LEA02E-CIGARETTE, KIT | Division of West Coast Imports (DWCI) | |
| 12/1/2025 | 98LEA02E-CIGARETTE, KIT | Division of West Coast Imports (DWCI) | |
| 10/12/2024 | 98LCA01E-CIGARETTE | Division of West Coast Imports (DWCI) | |
| 10/12/2024 | 98LCA01E-CIGARETTE | Division of West Coast Imports (DWCI) | |
| 10/12/2024 | 98LCA01E-CIGARETTE | Division of West Coast Imports (DWCI) | |
| 10/12/2024 | 98LCA01E-CIGARETTE | Division of West Coast Imports (DWCI) | |
| 10/12/2024 | 98LCA01E-CIGARETTE | Division of West Coast Imports (DWCI) | |
| 10/12/2024 | 98LCA01E-CIGARETTE | Division of West Coast Imports (DWCI) | |
| 10/12/2024 | 98LCA01E-CIGARETTE | Division of West Coast Imports (DWCI) |
Frequently Asked Questions
What is Shenzhen SKE Technology co., Ltd's FDA import refusal history?
Shenzhen SKE Technology co., Ltd (FEI: 3031468591) has 9 FDA import refusal record(s) in our database, spanning from 10/12/2024 to 12/1/2025.
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 SKE Technology co., Ltd's FEI number is 3031468591.
What types of violations has Shenzhen SKE Technology co., Ltd received?
Shenzhen SKE Technology co., Ltd has been cited for 3 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 SKE Technology co., Ltd come from?
All FDA import refusal data for Shenzhen SKE 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.