SHENZHEN BIG OCEAN TECHNOLOGY
⚠️ High Risk
FEI: 3030639604 • Shenzhen, Guangdong • CHINA
FEI Number
3030639604
Location
Shenzhen, Guangdong
Country
CHINAAddress
Industrial Park. Fl 3., Buliding 8 Huachu, Shenzhen, Guangdong, 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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/31/2024 | 98MAA07ENDS CARTRIDGE | Division of Northern Border Imports (DNBI) | |
| 12/31/2024 | 98MAA07ENDS CARTRIDGE | Division of Northern Border Imports (DNBI) | |
| 12/31/2024 | 98MAA07ENDS CARTRIDGE | Division of Northern Border Imports (DNBI) | |
| 12/31/2024 | 98MAA07ENDS CARTRIDGE | Division of Northern Border Imports (DNBI) | |
| 12/31/2024 | 98MAA07ENDS CARTRIDGE | Division of Northern Border Imports (DNBI) | |
| 12/31/2024 | 98MAA07ENDS CARTRIDGE | Division of Northern Border Imports (DNBI) | |
| 12/31/2024 | 98MAA07ENDS CARTRIDGE | Division of Northern Border Imports (DNBI) | |
| 12/31/2024 | 98MAA07ENDS CARTRIDGE | Division of Northern Border Imports (DNBI) |
Frequently Asked Questions
What is SHENZHEN BIG OCEAN TECHNOLOGY's FDA import refusal history?
SHENZHEN BIG OCEAN TECHNOLOGY (FEI: 3030639604) has 8 FDA import refusal record(s) in our database, spanning from 12/31/2024 to 12/31/2024.
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 BIG OCEAN TECHNOLOGY's FEI number is 3030639604.
What types of violations has SHENZHEN BIG OCEAN TECHNOLOGY received?
SHENZHEN BIG OCEAN TECHNOLOGY 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 BIG OCEAN TECHNOLOGY come from?
All FDA import refusal data for SHENZHEN BIG OCEAN TECHNOLOGY 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.