HUAZHIHENG TECHNOLOGY CO., LTD(SHENZHEN)
⚠️ High Risk
FEI: 3030080787 • Guangdong • CHINA
FEI Number
3030080787
Location
Guangdong
Country
CHINAAddress
201, Building 5, Creative Cultural Industrial Park, Zhoushi Road, Hezhou Community, Hangcheng, , 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.
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 |
|---|---|---|---|
| 1/19/2024 | 98MCA07ENDS CARTRIDGE | Division of Northern Border Imports (DNBI) | |
| 1/19/2024 | 98MCA07ENDS CARTRIDGE | Division of Northern Border Imports (DNBI) | |
| 1/19/2024 | 98MCA07ENDS CARTRIDGE | Division of Northern Border Imports (DNBI) | |
| 1/19/2024 | 98MCA07ENDS CARTRIDGE | Division of Northern Border Imports (DNBI) | |
| 1/19/2024 | 98MCA07ENDS CARTRIDGE | Division of Northern Border Imports (DNBI) | |
| 1/19/2024 | 98MCA07ENDS CARTRIDGE | Division of Northern Border Imports (DNBI) | |
| 1/19/2024 | 98MCA07ENDS CARTRIDGE | Division of Northern Border Imports (DNBI) | |
| 1/19/2024 | 98MCA07ENDS CARTRIDGE | Division of Northern Border Imports (DNBI) | |
| 1/19/2024 | 98MCA07ENDS CARTRIDGE | Division of Northern Border Imports (DNBI) | |
| 1/19/2024 | 98LAA99ELECTRONIC NICOTINE DELIVERY SYSTEM, NEC | Division of Northern Border Imports (DNBI) |
Frequently Asked Questions
What is HUAZHIHENG TECHNOLOGY CO., LTD(SHENZHEN)'s FDA import refusal history?
HUAZHIHENG TECHNOLOGY CO., LTD(SHENZHEN) (FEI: 3030080787) has 10 FDA import refusal record(s) in our database, spanning from 1/19/2024 to 1/19/2024.
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. HUAZHIHENG TECHNOLOGY CO., LTD(SHENZHEN)'s FEI number is 3030080787.
What types of violations has HUAZHIHENG TECHNOLOGY CO., LTD(SHENZHEN) received?
HUAZHIHENG TECHNOLOGY CO., LTD(SHENZHEN) 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 HUAZHIHENG TECHNOLOGY CO., LTD(SHENZHEN) come from?
All FDA import refusal data for HUAZHIHENG TECHNOLOGY CO., LTD(SHENZHEN) 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.