Shenzhen Microprofit Biotech Co., Ltd.
⚠️ High Risk
FEI: 3016884814 • Shenzhen, Guangdong • CHINA
FEI Number
3016884814
Location
Shenzhen, Guangdong
Country
CHINAAddress
Room 1001 of Unit 1, Building 2, Hongchuang Technology Center, Xikeng Community, Fucheng Sub-district, Longhua District, 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
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.
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 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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 11/21/2025 | 83QYTOVER-THE-COUNTER COVID-19 ANTIGEN TEST | Division of Northeast Imports (DNEI) | |
| 9/24/2025 | 83QQXRESPIRATORY SPECIMEN NUCLEIC ACID SARS-COV-2 TEST | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 9/24/2025 | 80FMHCONTAINER, SPECIMEN | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 9/24/2025 | 83PSZDEVICES DETECTING INFLUENZA A, B, AND C VIRUS ANTIGENS | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 9/24/2025 | 83PSZDEVICES DETECTING INFLUENZA A, B, AND C VIRUS ANTIGENS | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 9/24/2025 | 83PSZDEVICES DETECTING INFLUENZA A, B, AND C VIRUS ANTIGENS | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 6/23/2025 | 83QWBOVER-THE-COUNTER MOLECULAR TEST TO DETECT SARS-COV-2 | Division of Southeast Imports (DSEI) | |
| 6/17/2025 | 88PPMGENERAL PURPOSE REAGENT | Division of Southeast Imports (DSEI) | |
| 6/13/2025 | 77NRKKIT, TEST, OLFACTORY | Division of Southeast Imports (DSEI) | |
| 6/1/2025 | 83QMNCOVID-19 MULTI-ANALYTE ANTIGEN DEVICE | Division of Southeast Imports (DSEI) | |
| 5/29/2025 | 83QYTOVER-THE-COUNTER COVID-19 ANTIGEN TEST | Division of Southeast Imports (DSEI) | |
| 5/27/2025 | 83QLWCOVID-19 TEST HOME COLLECTION KIT DEVICES | Division of Southeast Imports (DSEI) | |
| 5/12/2025 | 83QMNCOVID-19 MULTI-ANALYTE ANTIGEN DEVICE | Division of Southeast Imports (DSEI) | |
| 5/9/2025 | 83QMNCOVID-19 MULTI-ANALYTE ANTIGEN DEVICE | Division of Southeast Imports (DSEI) | |
| 4/28/2025 | 83QYTOVER-THE-COUNTER COVID-19 ANTIGEN TEST | Division of Southeast Imports (DSEI) | |
| 4/14/2025 | 83PSZDEVICES DETECTING INFLUENZA A, B, AND C VIRUS ANTIGENS | Division of Southeast Imports (DSEI) | |
| 3/27/2024 | 83QLWCOVID-19 TEST HOME COLLECTION KIT DEVICES | Division of Southeast Imports (DSEI) | |
| 4/19/2023 | 83QKPCORONAVIRUS ANTIGEN DETECTION TEST SYSTEM. | Division of Southeast Imports (DSEI) | |
| 8/12/2020 | 83QKOREAGENT, CORONAVIRUS SEROLOGICAL | Division of Southeast Imports (DSEI) | |
| 8/12/2020 | 83QKOREAGENT, CORONAVIRUS SEROLOGICAL | Division of Southeast Imports (DSEI) | |
| 8/12/2020 | 83QKOREAGENT, CORONAVIRUS SEROLOGICAL | Division of Southeast Imports (DSEI) | |
| 7/14/2020 | 83QKOREAGENT, CORONAVIRUS SEROLOGICAL | 508NO 510(K) | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Shenzhen Microprofit Biotech Co., Ltd.'s FDA import refusal history?
Shenzhen Microprofit Biotech Co., Ltd. (FEI: 3016884814) has 22 FDA import refusal record(s) in our database, spanning from 7/14/2020 to 11/21/2025.
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 Microprofit Biotech Co., Ltd.'s FEI number is 3016884814.
What types of violations has Shenzhen Microprofit Biotech Co., Ltd. received?
Shenzhen Microprofit Biotech Co., Ltd. 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 Shenzhen Microprofit Biotech Co., Ltd. come from?
All FDA import refusal data for Shenzhen Microprofit Biotech 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.