Wuhan Life Origin Biotech Joint Stock Co., Ltd.
⚠️ Moderate Risk
FEI: 3017393598 • Wuhan, Hubei • CHINA
FEI Number
3017393598
Location
Wuhan, Hubei
Country
CHINAAddress
Wuhan Hi-Tech Medical Devices Park, Building B11, #818 Gaoxin Road, Donghu Hi, Tech Development Area, Wuhan, Hubei, China
Moderate Risk
FDA Import Risk Assessment
This firm has a moderate history of FDA import refusals. Some attention may be warranted.
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 2/9/2022 | 83QLWCOVID-19 TEST HOME COLLECTION KIT DEVICES | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 9/2/2020 | 83QKPCORONAVIRUS ANTIGEN DETECTION TEST SYSTEM. | 237NO PMA | Division of Southeast Imports (DSEI) |
| 9/2/2020 | 83QKPCORONAVIRUS ANTIGEN DETECTION TEST SYSTEM. | 237NO PMA | Division of Southeast Imports (DSEI) |
| 8/11/2020 | 83QKOREAGENT, CORONAVIRUS SEROLOGICAL | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 6/1/2020 | 83NWYTEST, QUALITATIVE, DETECTION OF DENGUE IGM AND IGG ANTIBODIES | 508NO 510(K) | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Wuhan Life Origin Biotech Joint Stock Co., Ltd.'s FDA import refusal history?
Wuhan Life Origin Biotech Joint Stock Co., Ltd. (FEI: 3017393598) has 5 FDA import refusal record(s) in our database, spanning from 6/1/2020 to 2/9/2022.
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. Wuhan Life Origin Biotech Joint Stock Co., Ltd.'s FEI number is 3017393598.
What types of violations has Wuhan Life Origin Biotech Joint Stock Co., Ltd. received?
Wuhan Life Origin Biotech Joint Stock Co., Ltd. has been cited for 2 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 Wuhan Life Origin Biotech Joint Stock Co., Ltd. come from?
All FDA import refusal data for Wuhan Life Origin Biotech Joint Stock 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.