Suzhou Soochow University Saier Immuno Biotech Co Ltd
⚠️ Moderate Risk
FEI: 3017958524 • Suzhou, Jiangsu • CHINA
FEI Number
3017958524
Location
Suzhou, Jiangsu
Country
CHINAAddress
No. 502 Zhongnan Road, , Suzhou, Jiangsu, 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 |
|---|---|---|---|
| 1/20/2022 | 83QKPCORONAVIRUS ANTIGEN DETECTION TEST SYSTEM. | 508NO 510(K) | Division of West Coast Imports (DWCI) |
Frequently Asked Questions
What is Suzhou Soochow University Saier Immuno Biotech Co Ltd's FDA import refusal history?
Suzhou Soochow University Saier Immuno Biotech Co Ltd (FEI: 3017958524) has 1 FDA import refusal record(s) in our database, spanning from 1/20/2022 to 1/20/2022.
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. Suzhou Soochow University Saier Immuno Biotech Co Ltd's FEI number is 3017958524.
What types of violations has Suzhou Soochow University Saier Immuno Biotech Co Ltd received?
Suzhou Soochow University Saier Immuno Biotech 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 Suzhou Soochow University Saier Immuno Biotech Co Ltd come from?
All FDA import refusal data for Suzhou Soochow University Saier Immuno 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.