NEW GENE (HANGZHOU) BIOENGINEERING
⚠️ High Risk
FEI: 3021420890 • Hangzhou, Zhejiang • CHINA
FEI Number
3021420890
Location
Hangzhou, Zhejiang
Country
CHINAAddress
Building 5 Room 1606 Floor 16, 688 Binan Road; Xixingzhen Binjiang, Hangzhou, Zhejiang, 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
NO 510(K)
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.
NO PMA
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the device appears to be a Class III device and does not appear to have in effect an approved application for premarket approval pursuant to Section 515 of the Act, or an exemption pursuant to Section 520(g)(1).
NOT LISTED
It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 5/27/2025 | 83QLWCOVID-19 TEST HOME COLLECTION KIT DEVICES | Division of Southeast Imports (DSEI) | |
| 6/29/2022 | 83QKPCORONAVIRUS ANTIGEN DETECTION TEST SYSTEM. | Division of Southeast Imports (DSEI) | |
| 4/20/2022 | 83QLWCOVID-19 TEST HOME COLLECTION KIT DEVICES | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 4/14/2022 | 83QLWCOVID-19 TEST HOME COLLECTION KIT DEVICES | Division of Southeast Imports (DSEI) | |
| 3/16/2022 | 83QJRREAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID | Division of Southeast Imports (DSEI) | |
| 3/10/2022 | 83QLWCOVID-19 TEST HOME COLLECTION KIT DEVICES | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 3/2/2022 | 83QKPCORONAVIRUS ANTIGEN DETECTION TEST SYSTEM. | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 2/28/2022 | 83QLWCOVID-19 TEST HOME COLLECTION KIT DEVICES | Division of Southeast Imports (DSEI) | |
| 2/8/2022 | 83QLWCOVID-19 TEST HOME COLLECTION KIT DEVICES | Division of Southeast Imports (DSEI) | |
| 1/26/2022 | 83QKOREAGENT, CORONAVIRUS SEROLOGICAL | 508NO 510(K) | Division of Northern Border Imports (DNBI) |
Frequently Asked Questions
What is NEW GENE (HANGZHOU) BIOENGINEERING's FDA import refusal history?
NEW GENE (HANGZHOU) BIOENGINEERING (FEI: 3021420890) has 10 FDA import refusal record(s) in our database, spanning from 1/26/2022 to 5/27/2025.
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. NEW GENE (HANGZHOU) BIOENGINEERING's FEI number is 3021420890.
What types of violations has NEW GENE (HANGZHOU) BIOENGINEERING received?
NEW GENE (HANGZHOU) BIOENGINEERING has been cited for 4 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 NEW GENE (HANGZHOU) BIOENGINEERING come from?
All FDA import refusal data for NEW GENE (HANGZHOU) BIOENGINEERING 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.