Dongguan Hengtai Biotechnology Co Ltd
⚠️ High Risk
FEI: 3023420039 • Dongguan • CHINA
FEI Number
3023420039
Location
Dongguan
Country
CHINAAddress
Room 5028, No. 915, Chang'an Section, Tai'an Road, Dongguan, , 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 |
|---|---|---|---|
| 10/12/2023 | 98LCA11VAPE PEN | Division of Northern Border Imports (DNBI) | |
| 10/12/2023 | 98LCA11VAPE PEN | Division of Northern Border Imports (DNBI) | |
| 10/12/2023 | 98LCA11VAPE PEN | Division of Northern Border Imports (DNBI) | |
| 10/12/2023 | 98LCA11VAPE PEN | Division of Northern Border Imports (DNBI) | |
| 10/12/2023 | 98LCA11VAPE PEN | Division of Northern Border Imports (DNBI) | |
| 5/31/2023 | 98MAA03ENDS ATOMIZER | Division of Northern Border Imports (DNBI) | |
| 5/20/2023 | 98MAA03ENDS ATOMIZER | Division of Northern Border Imports (DNBI) | |
| 5/20/2023 | 98MAA03ENDS ATOMIZER | Division of Northern Border Imports (DNBI) | |
| 5/20/2023 | 98MAA03ENDS ATOMIZER | Division of Northern Border Imports (DNBI) | |
| 4/25/2023 | 98MAA03ENDS ATOMIZER | Division of Northern Border Imports (DNBI) |
Frequently Asked Questions
What is Dongguan Hengtai Biotechnology Co Ltd's FDA import refusal history?
Dongguan Hengtai Biotechnology Co Ltd (FEI: 3023420039) has 10 FDA import refusal record(s) in our database, spanning from 4/25/2023 to 10/12/2023.
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 Hengtai Biotechnology Co Ltd's FEI number is 3023420039.
What types of violations has Dongguan Hengtai Biotechnology Co Ltd received?
Dongguan Hengtai Biotechnology 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 Dongguan Hengtai Biotechnology Co Ltd come from?
All FDA import refusal data for Dongguan Hengtai Biotechnology 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.