SHENZHEN LVSHIYUAN BIOTECHNOLOGY
⚠️ High Risk
FEI: 3012615959 • Shenzhen, Dongguan • CHINA
FEI Number
3012615959
Location
Shenzhen, Dongguan
Country
CHINAAddress
Building No.2 D, Industrial Avenue, Buxin Village, Buxin Community, Dapeng Subdistrict Office, Dapeng New Dist, Shenzhen, 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
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.
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 REGISTR
The article appears to be an electronic product that does not comply with an applicable standard as prescribed by Section 534 because no reporting has been provided as required by Section 537(b).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/5/2025 | 83QWBOVER-THE-COUNTER MOLECULAR TEST TO DETECT SARS-COV-2 | 508NO 510(K) | Division of Northern Border Imports (DNBI) |
| 11/3/2025 | 83QYTOVER-THE-COUNTER COVID-19 ANTIGEN TEST | Division of West Coast Imports (DWCI) | |
| 4/7/2025 | 83QYTOVER-THE-COUNTER COVID-19 ANTIGEN TEST | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 3/20/2025 | 83QLTCOVID-19 MULTI-ANALYTE RESPIRATORY PANEL NUCLEIC ACID DEVICES | Division of Southeast Imports (DSEI) | |
| 3/12/2022 | 83QKPCORONAVIRUS ANTIGEN DETECTION TEST SYSTEM. | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 2/23/2022 | 83QLWCOVID-19 TEST HOME COLLECTION KIT DEVICES | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 12/16/2021 | 83QKPCORONAVIRUS ANTIGEN DETECTION TEST SYSTEM. | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 2/3/2021 | 83QKOREAGENT, CORONAVIRUS SEROLOGICAL | Division of Southeast Imports (DSEI) | |
| 9/4/2020 | 80LKBPAD, ALCOHOL, DEVICE DISINFECTANT | Division of Southeast Imports (DSEI) | |
| 7/8/2020 | 80LKBPAD, ALCOHOL, DEVICE DISINFECTANT | Division of Southeast Imports (DSEI) | |
| 6/9/2020 | 80LKBPAD, ALCOHOL, DEVICE DISINFECTANT | Division of Northern Border Imports (DNBI) | |
| 6/5/2020 | 83QKPCORONAVIRUS ANTIGEN DETECTION TEST SYSTEM. | 508NO 510(K) | Division of West Coast Imports (DWCI) |
| 6/4/2020 | 80LKBPAD, ALCOHOL, DEVICE DISINFECTANT | Division of Northern Border Imports (DNBI) | |
| 5/22/2020 | 80LKBPAD, ALCOHOL, DEVICE DISINFECTANT | Division of Northern Border Imports (DNBI) | |
| 5/20/2020 | 62HAY05ETHYL ALCOHOL (ANTI-MICROBIAL) | Division of Northern Border Imports (DNBI) | |
| 5/19/2020 | 83QJRREAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID | Division of West Coast Imports (DWCI) | |
| 5/14/2020 | 83QKPCORONAVIRUS ANTIGEN DETECTION TEST SYSTEM. | 508NO 510(K) | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is SHENZHEN LVSHIYUAN BIOTECHNOLOGY's FDA import refusal history?
SHENZHEN LVSHIYUAN BIOTECHNOLOGY (FEI: 3012615959) has 17 FDA import refusal record(s) in our database, spanning from 5/14/2020 to 12/5/2025.
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. SHENZHEN LVSHIYUAN BIOTECHNOLOGY's FEI number is 3012615959.
What types of violations has SHENZHEN LVSHIYUAN BIOTECHNOLOGY received?
SHENZHEN LVSHIYUAN BIOTECHNOLOGY 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 SHENZHEN LVSHIYUAN BIOTECHNOLOGY come from?
All FDA import refusal data for SHENZHEN LVSHIYUAN BIOTECHNOLOGY 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.