Sunwell Biotech Co Ltd
✅ Low Risk
FEI: 3009663347 • Nantong, Jiangsu • CHINA
FEI Number
3009663347
Location
Nantong, Jiangsu
Country
CHINAAddress
Gangzha, No 9 Yongxing Avenue; Economic Development Zone, Nantong, Jiangsu, 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
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).
LACKS FIRM
The article is in package form and appears to not bear a label containing the name and place of business of the manufacturer, packer, or distributor.
LACKS N/C
The article is in package form and appears to not have a label containing an accurate statement of the quantity of the contents in terms of weight, measure or numerical count and no variations or exemptions have been prescribed by regs.
DV NAME
The article appears to be a device and its labeling fails to bear the proprietary or established name.
Refusal History
Frequently Asked Questions
What is Sunwell Biotech Co Ltd's FDA import refusal history?
Sunwell Biotech Co Ltd (FEI: 3009663347) has 1 FDA import refusal record(s) in our database, spanning from 8/27/2012 to 8/27/2012.
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. Sunwell Biotech Co Ltd's FEI number is 3009663347.
What types of violations has Sunwell Biotech Co Ltd received?
Sunwell Biotech 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 Sunwell Biotech Co Ltd come from?
All FDA import refusal data for Sunwell 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.