Jiangsu Superbio Biomedical (Nanjing) Co., Ltd.
⚠️ High Risk
FEI: 3016653637 • Nanjing, Jiangsu • CHINA
FEI Number
3016653637
Location
Nanjing, Jiangsu
Country
CHINAAddress
Rooms 507-511, Block A, Sino-Danish Ecological Life Science Industrial Park, No.3-1, Xinjinhu Road; Gaoxin Jizhu Kaifaqu Pukou District, Nanjing, Jiangsu, China
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable violations.
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.
DIRECTIONS
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.
WARNINGS
It appears to lack adequate warning against use in a pathological condition or by children where it may be dangerous to health or against an unsafe dose, method, administering duration, application, in manner/form, to protect users.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 10/8/2024 | 88PPMGENERAL PURPOSE REAGENT | Division of Southeast Imports (DSEI) | |
| 9/18/2020 | 83QKOREAGENT, CORONAVIRUS SEROLOGICAL | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 8/22/2020 | 83QKOREAGENT, CORONAVIRUS SEROLOGICAL | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 8/14/2020 | 83QKOREAGENT, CORONAVIRUS SEROLOGICAL | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 7/14/2020 | 83QKOREAGENT, CORONAVIRUS SEROLOGICAL | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 7/6/2020 | 83QKOREAGENT, CORONAVIRUS SEROLOGICAL | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 6/19/2020 | 83QKOREAGENT, CORONAVIRUS SEROLOGICAL | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 6/3/2020 | 83QKOREAGENT, CORONAVIRUS SEROLOGICAL | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 6/1/2020 | 83QKOREAGENT, CORONAVIRUS SEROLOGICAL | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 5/27/2020 | 83QKOREAGENT, CORONAVIRUS SEROLOGICAL | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 5/26/2020 | 83QKOREAGENT, CORONAVIRUS SEROLOGICAL | Division of Southeast Imports (DSEI) | |
| 5/21/2020 | 83QKOREAGENT, CORONAVIRUS SEROLOGICAL | Division of Southeast Imports (DSEI) | |
| 5/21/2020 | 83QJRREAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Jiangsu Superbio Biomedical (Nanjing) Co., Ltd.'s FDA import refusal history?
Jiangsu Superbio Biomedical (Nanjing) Co., Ltd. (FEI: 3016653637) has 13 FDA import refusal record(s) in our database, spanning from 5/21/2020 to 10/8/2024.
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 Superbio Biomedical (Nanjing) Co., Ltd.'s FEI number is 3016653637.
What types of violations has Jiangsu Superbio Biomedical (Nanjing) Co., Ltd. received?
Jiangsu Superbio Biomedical (Nanjing) Co., Ltd. has been cited for 4 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 Superbio Biomedical (Nanjing) Co., Ltd. come from?
All FDA import refusal data for Jiangsu Superbio Biomedical (Nanjing) 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.