DONGGUAN SHIKAI TECHNOLOGY CO.,LTD
⚠️ Moderate Risk
FEI: 3022359476 • Dongguan, Guangdong • CHINA
FEI Number
3022359476
Location
Dongguan, Guangdong
Country
CHINAAddress
Shayong Road, No. 6 Humen Shajiao Shequtow 9898, Dongguan, Guangdong, China
Moderate Risk
FDA Import Risk Assessment
This firm has a moderate history of FDA import refusals. Some attention may be warranted.
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).
TPLACKFIRM
This article is subject to refusal of admission pursuant to section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) because it is a tobacco product in package form that appears to be misbranded under section 903(a)(2)(A) of the FD&C Act in that the label does not contain the name and place of business of the tobacco product manufacturer, packer or distributor.
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.
TPNICWARN
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 appears to be misbranded under section 903(a)(7)(B) in that it is sold or distributed in violation of regulations prescribed under 906(d), namely its package fails to bear the required warning statement "WARNING: This product contains nicotine. Nicotine is an addictive chemical." Or if applicable the required statement "This product is made from tobacco."
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 10/16/2024 | 98LAA02E-CIGARETTE, KIT | Division of Northern Border Imports (DNBI) | |
| 10/16/2024 | 98LAA02E-CIGARETTE, KIT | Division of Northern Border Imports (DNBI) | |
| 10/16/2024 | 98LAA02E-CIGARETTE, KIT | Division of Northern Border Imports (DNBI) |
Frequently Asked Questions
What is DONGGUAN SHIKAI TECHNOLOGY CO.,LTD's FDA import refusal history?
DONGGUAN SHIKAI TECHNOLOGY CO.,LTD (FEI: 3022359476) has 3 FDA import refusal record(s) in our database, spanning from 10/16/2024 to 10/16/2024.
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. DONGGUAN SHIKAI TECHNOLOGY CO.,LTD's FEI number is 3022359476.
What types of violations has DONGGUAN SHIKAI TECHNOLOGY CO.,LTD received?
DONGGUAN SHIKAI TECHNOLOGY CO.,LTD has been cited for 5 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 DONGGUAN SHIKAI TECHNOLOGY CO.,LTD come from?
All FDA import refusal data for DONGGUAN SHIKAI 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.