TONG XIN ELECTRONIC COMMERCE CO
✅ Low Risk
FEI: 3013826583 • Huizhou, Guangdong • CHINA
FEI Number
3013826583
Location
Huizhou, Guangdong
Country
CHINAAddress
San Shek Wan Region Tec, , Huizhou, Guangdong, 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).
LENS CERT
The lenses are declared by accompanying certificate to meet the requirements for impact-resistant lenses in 21 CFR 801.410 but does not appear to be impact-resistant.
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 TONG XIN ELECTRONIC COMMERCE CO's FDA import refusal history?
TONG XIN ELECTRONIC COMMERCE CO (FEI: 3013826583) has 1 FDA import refusal record(s) in our database, spanning from 11/14/2017 to 11/14/2017.
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. TONG XIN ELECTRONIC COMMERCE CO's FEI number is 3013826583.
What types of violations has TONG XIN ELECTRONIC COMMERCE CO received?
TONG XIN ELECTRONIC COMMERCE CO 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 TONG XIN ELECTRONIC COMMERCE CO come from?
All FDA import refusal data for TONG XIN ELECTRONIC COMMERCE CO 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.