SUZHOU HERUI BIOMED CO., LTD
⚠️ Moderate Risk
FEI: 3016789796 • Suzhou, Jiangsu • CHINA
FEI Number
3016789796
Location
Suzhou, Jiangsu
Country
CHINAAddress
313, Building B2, Biological Nanometer Park, No.2 Room 310, 312, 218 Xinghu Street; Suzhou Industrial Park, 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 |
|---|---|---|---|
| 6/3/2020 | 83QJRREAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID | 508NO 510(K) | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is SUZHOU HERUI BIOMED CO., LTD's FDA import refusal history?
SUZHOU HERUI BIOMED CO., LTD (FEI: 3016789796) has 1 FDA import refusal record(s) in our database, spanning from 6/3/2020 to 6/3/2020.
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 HERUI BIOMED CO., LTD's FEI number is 3016789796.
What types of violations has SUZHOU HERUI BIOMED CO., LTD received?
SUZHOU HERUI BIOMED 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 HERUI BIOMED CO., LTD come from?
All FDA import refusal data for SUZHOU HERUI BIOMED 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.