Shanghai World Bio Tech Co Ltd
✅ Low Risk
FEI: 3007645719 • Shanghai, Shanghai • CHINA
FEI Number
3007645719
Location
Shanghai, Shanghai
Country
CHINAAddress
1157 Jia Xin Highway, , Shanghai, Shanghai, China
Low Risk
FDA Import Risk Assessment
This firm has a minimal history of FDA import refusals with low-severity 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
REGISTERED
It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 11/22/2016 | 89IMEPACK, HOT OR COLD, REUSEABLE | 341REGISTERED | Division of Northeast Imports (DNEI) |
Frequently Asked Questions
What is Shanghai World Bio Tech Co Ltd's FDA import refusal history?
Shanghai World Bio Tech Co Ltd (FEI: 3007645719) has 1 FDA import refusal record(s) in our database, spanning from 11/22/2016 to 11/22/2016.
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. Shanghai World Bio Tech Co Ltd's FEI number is 3007645719.
What types of violations has Shanghai World Bio Tech Co Ltd received?
Shanghai World Bio Tech 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 Shanghai World Bio Tech Co Ltd come from?
All FDA import refusal data for Shanghai World Bio Tech 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.