Yangzhou Tongfun Red International Trad
⚠️ Moderate Risk
FEI: 3007481575 • Yangzhou City • CHINA
FEI Number
3007481575
Location
Yangzhou City
Country
CHINAAddress
No 362 Shuguang Road, , Yangzhou City, , 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
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).
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
Frequently Asked Questions
What is Yangzhou Tongfun Red International Trad's FDA import refusal history?
Yangzhou Tongfun Red International Trad (FEI: 3007481575) has 3 FDA import refusal record(s) in our database, spanning from 11/30/2009 to 1/2/2018.
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. Yangzhou Tongfun Red International Trad's FEI number is 3007481575.
What types of violations has Yangzhou Tongfun Red International Trad received?
Yangzhou Tongfun Red International Trad 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 Yangzhou Tongfun Red International Trad come from?
All FDA import refusal data for Yangzhou Tongfun Red International Trad 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.