Ters Electronic Ltd
⚠️ Moderate Risk
FEI: 3008367079 • Shenzhenshenzhen • CHINA
FEI Number
3008367079
Location
Shenzhenshenzhen
Country
CHINAAddress
6th Floor A2 Building Huafengindustrial, , Shenzhenshenzhen, , 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).
NO REGISTR
The article appears to be an electronic product that does not comply with an applicable standard as prescribed by Section 534 because no reporting has been provided as required by Section 537(b).
Refusal History
Frequently Asked Questions
What is Ters Electronic Ltd's FDA import refusal history?
Ters Electronic Ltd (FEI: 3008367079) has 2 FDA import refusal record(s) in our database, spanning from 10/25/2010 to 10/25/2010.
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. Ters Electronic Ltd's FEI number is 3008367079.
What types of violations has Ters Electronic Ltd received?
Ters Electronic Ltd 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 Ters Electronic Ltd come from?
All FDA import refusal data for Ters Electronic 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.