Teng Yuan Daimond Tool Factory
✅ Low Risk
FEI: 3009437878 • Henan • 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).
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 Teng Yuan Daimond Tool Factory's FDA import refusal history?
Teng Yuan Daimond Tool Factory (FEI: 3009437878) has 1 FDA import refusal record(s) in our database, spanning from 5/11/2012 to 5/11/2012.
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. Teng Yuan Daimond Tool Factory's FEI number is 3009437878.
What types of violations has Teng Yuan Daimond Tool Factory received?
Teng Yuan Daimond Tool Factory 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 Teng Yuan Daimond Tool Factory come from?
All FDA import refusal data for Teng Yuan Daimond Tool Factory 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.