TENART BIOTECH LIMITED
✅ Low Risk
FEI: 3012648475 • Taipei • TAIWAN
FEI Number
3012648475
Location
Taipei
Country
TAIWANAddress
550, 7 F, Ruiguang Road; NE, Taipei, , Taiwan
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).
INCONSPICU
Information required by the Act to be on the label or labeling does not appear to be conspicuous enough as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use.
Refusal History
Frequently Asked Questions
What is TENART BIOTECH LIMITED's FDA import refusal history?
TENART BIOTECH LIMITED (FEI: 3012648475) has 1 FDA import refusal record(s) in our database, spanning from 9/7/2016 to 9/7/2016.
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. TENART BIOTECH LIMITED's FEI number is 3012648475.
What types of violations has TENART BIOTECH LIMITED received?
TENART BIOTECH LIMITED 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 TENART BIOTECH LIMITED come from?
All FDA import refusal data for TENART BIOTECH LIMITED 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.