SHANGHAI XINTONG TRADE CO. LTD
⚠️ Moderate Risk
FEI: 3012723472 • SHANGHAI • CHINA
FEI Number
3012723472
Location
SHANGHAI
Country
CHINAAddress
ROOM 5140, NO 22 LANE 1, , SHANGHAI, , 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
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.
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.
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
Frequently Asked Questions
What is SHANGHAI XINTONG TRADE CO. LTD's FDA import refusal history?
SHANGHAI XINTONG TRADE CO. LTD (FEI: 3012723472) has 1 FDA import refusal record(s) in our database, spanning from 2/28/2017 to 2/28/2017.
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 XINTONG TRADE CO. LTD's FEI number is 3012723472.
What types of violations has SHANGHAI XINTONG TRADE CO. LTD received?
SHANGHAI XINTONG TRADE CO. LTD has been cited for 3 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 XINTONG TRADE CO. LTD come from?
All FDA import refusal data for SHANGHAI XINTONG TRADE 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.