Beijing Kewei Clinical Diagnostic Reagent Inc
⚠️ Moderate Risk
FEI: 3011456825 • Huairou District, Beijing • CHINA
FEI Number
3011456825
Location
Huairou District, Beijing
Country
CHINAAddress
No.7, Xi Yi Road, Yanqihe Yanqi Economic, No. 7 Yan Qi He, Xi Yi Rd., Huairou District, Beijing, 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.
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 |
|---|---|---|---|
| 3/28/2022 | 83QLWCOVID-19 TEST HOME COLLECTION KIT DEVICES | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 8/3/2020 | 83QKPCORONAVIRUS ANTIGEN DETECTION TEST SYSTEM. | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 5/11/2015 | 85LHDDEVICE, FERTILITY DIAGNOSTIC, PROCEPTIVE | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is Beijing Kewei Clinical Diagnostic Reagent Inc's FDA import refusal history?
Beijing Kewei Clinical Diagnostic Reagent Inc (FEI: 3011456825) has 3 FDA import refusal record(s) in our database, spanning from 5/11/2015 to 3/28/2022.
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. Beijing Kewei Clinical Diagnostic Reagent Inc's FEI number is 3011456825.
What types of violations has Beijing Kewei Clinical Diagnostic Reagent Inc received?
Beijing Kewei Clinical Diagnostic Reagent Inc has been cited for 3 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 Kewei Clinical Diagnostic Reagent Inc come from?
All FDA import refusal data for Beijing Kewei Clinical Diagnostic Reagent Inc 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.