JIANGSU KONSUNG BIO-MEDICAL SCIENCE AND TECHNOLOGY CO LTD
⚠️ Moderate Risk
FEI: 3016859940 • Zhen Jiang, Jiangsu • CHINA
FEI Number
3016859940
Location
Zhen Jiang, Jiangsu
Country
CHINAAddress
No. 8 Shengchang West Road, Kaifa Yunyangzhen Danyang, Zhen Jiang, 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.
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 2/11/2022 | 83QLWCOVID-19 TEST HOME COLLECTION KIT DEVICES | 508NO 510(K) | Division of Northern Border Imports (DNBI) |
| 1/15/2022 | 68MYG02BIOCHEMICAL ANALYZER (NONHUMAN) | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 6/8/2021 | 88PPMGENERAL PURPOSE REAGENT | 508NO 510(K) | Division of Northern Border Imports (DNBI) |
Frequently Asked Questions
What is JIANGSU KONSUNG BIO-MEDICAL SCIENCE AND TECHNOLOGY CO LTD's FDA import refusal history?
JIANGSU KONSUNG BIO-MEDICAL SCIENCE AND TECHNOLOGY CO LTD (FEI: 3016859940) has 3 FDA import refusal record(s) in our database, spanning from 6/8/2021 to 2/11/2022.
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. JIANGSU KONSUNG BIO-MEDICAL SCIENCE AND TECHNOLOGY CO LTD's FEI number is 3016859940.
What types of violations has JIANGSU KONSUNG BIO-MEDICAL SCIENCE AND TECHNOLOGY CO LTD received?
JIANGSU KONSUNG BIO-MEDICAL SCIENCE AND TECHNOLOGY 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 JIANGSU KONSUNG BIO-MEDICAL SCIENCE AND TECHNOLOGY CO LTD come from?
All FDA import refusal data for JIANGSU KONSUNG BIO-MEDICAL SCIENCE AND TECHNOLOGY 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.