BEIJING DIAGREAT BIOTECHNOLOGIES Co Ltd
⚠️ Moderate Risk
FEI: 3016656474 • Beijing, Beijing • CHINA
FEI Number
3016656474
Location
Beijing, Beijing
Country
CHINAAddress
Xinhualian Science And Technology Building 3rd Floor, 5 Jaichuang Rd, Beijing, 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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 2/24/2022 | 83QLWCOVID-19 TEST HOME COLLECTION KIT DEVICES | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 1/21/2021 | 83QJRREAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 7/2/2020 | 83QKOREAGENT, CORONAVIRUS SEROLOGICAL | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 7/2/2020 | 83QKOREAGENT, CORONAVIRUS SEROLOGICAL | 508NO 510(K) | Division of West Coast Imports (DWCI) |
| 6/18/2020 | 83QKOREAGENT, CORONAVIRUS SEROLOGICAL | 508NO 510(K) | Division of Northern Border Imports (DNBI) |
Frequently Asked Questions
What is BEIJING DIAGREAT BIOTECHNOLOGIES Co Ltd's FDA import refusal history?
BEIJING DIAGREAT BIOTECHNOLOGIES Co Ltd (FEI: 3016656474) has 5 FDA import refusal record(s) in our database, spanning from 6/18/2020 to 2/24/2022.
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 DIAGREAT BIOTECHNOLOGIES Co Ltd's FEI number is 3016656474.
What types of violations has BEIJING DIAGREAT BIOTECHNOLOGIES Co Ltd received?
BEIJING DIAGREAT BIOTECHNOLOGIES Co Ltd has been cited for 1 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 DIAGREAT BIOTECHNOLOGIES Co Ltd come from?
All FDA import refusal data for BEIJING DIAGREAT BIOTECHNOLOGIES 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.