BEIJING HOTGEN BIOTECH CO LTD
⚠️ High Risk
FEI: 3017894300 • Beijing • CHINA
FEI Number
3017894300
Location
Beijing
Country
CHINAAddress
6th, 7th and 9th Buildings, No. 55 Qingfeng West Road, Daxing District, Beijing, , 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).
NO PMA/PDP
The article appears to be a class III dev.w/o an approved applic. for premarket approval, and/or a notice of completion of product development protocol filed per section 515(b) or exempt per sect.520(g)(1).
REGISTERED
It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 10/17/2025 | 83QKPCORONAVIRUS ANTIGEN DETECTION TEST SYSTEM. | Division of West Coast Imports (DWCI) | |
| 5/9/2025 | 83QKPCORONAVIRUS ANTIGEN DETECTION TEST SYSTEM. | Division of Southeast Imports (DSEI) | |
| 4/28/2025 | 83QWBOVER-THE-COUNTER MOLECULAR TEST TO DETECT SARS-COV-2 | Division of Southeast Imports (DSEI) | |
| 10/6/2022 | 83QKPCORONAVIRUS ANTIGEN DETECTION TEST SYSTEM. | Division of Southeast Imports (DSEI) | |
| 4/11/2022 | 83QQXRESPIRATORY SPECIMEN NUCLEIC ACID SARS-COV-2 TEST | Division of Southeast Imports (DSEI) | |
| 3/25/2022 | 83QKPCORONAVIRUS ANTIGEN DETECTION TEST SYSTEM. | Division of Southeast Imports (DSEI) | |
| 3/22/2022 | 83QKPCORONAVIRUS ANTIGEN DETECTION TEST SYSTEM. | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 3/22/2022 | 83QKPCORONAVIRUS ANTIGEN DETECTION TEST SYSTEM. | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 3/11/2022 | 83QKPCORONAVIRUS ANTIGEN DETECTION TEST SYSTEM. | 2380NO PMA/PDP | Division of Southeast Imports (DSEI) |
| 3/10/2022 | 83QLWCOVID-19 TEST HOME COLLECTION KIT DEVICES | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 3/8/2022 | 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) |
| 2/18/2022 | 83QKPCORONAVIRUS ANTIGEN DETECTION TEST SYSTEM. | 508NO 510(K) | Division of Northeast Imports (DNEI) |
| 2/10/2022 | 83QKPCORONAVIRUS ANTIGEN DETECTION TEST SYSTEM. | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 2/7/2022 | 83QLWCOVID-19 TEST HOME COLLECTION KIT DEVICES | Division of Southeast Imports (DSEI) | |
| 2/1/2022 | 83QKPCORONAVIRUS ANTIGEN DETECTION TEST SYSTEM. | 508NO 510(K) | Division of Northeast Imports (DNEI) |
| 1/31/2022 | 83QLWCOVID-19 TEST HOME COLLECTION KIT DEVICES | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 1/27/2022 | 83QLWCOVID-19 TEST HOME COLLECTION KIT DEVICES | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 1/18/2022 | 83QKPCORONAVIRUS ANTIGEN DETECTION TEST SYSTEM. | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 1/12/2022 | 83QKPCORONAVIRUS ANTIGEN DETECTION TEST SYSTEM. | 508NO 510(K) | Division of Northeast Imports (DNEI) |
| 1/3/2022 | 83QLWCOVID-19 TEST HOME COLLECTION KIT DEVICES | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 1/3/2022 | 83QLWCOVID-19 TEST HOME COLLECTION KIT DEVICES | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 12/19/2021 | 83QKPCORONAVIRUS ANTIGEN DETECTION TEST SYSTEM. | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 11/30/2021 | 83QKPCORONAVIRUS ANTIGEN DETECTION TEST SYSTEM. | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 11/5/2021 | 83QKPCORONAVIRUS ANTIGEN DETECTION TEST SYSTEM. | Division of Southeast Imports (DSEI) | |
| 10/4/2021 | 83QLWCOVID-19 TEST HOME COLLECTION KIT DEVICES | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is BEIJING HOTGEN BIOTECH CO LTD's FDA import refusal history?
BEIJING HOTGEN BIOTECH CO LTD (FEI: 3017894300) has 26 FDA import refusal record(s) in our database, spanning from 10/4/2021 to 10/17/2025.
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. BEIJING HOTGEN BIOTECH CO LTD's FEI number is 3017894300.
What types of violations has BEIJING HOTGEN BIOTECH CO LTD received?
BEIJING HOTGEN BIOTECH CO LTD has been cited for 6 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 BEIJING HOTGEN BIOTECH CO LTD come from?
All FDA import refusal data for BEIJING HOTGEN 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.