Jupiter Ortho Lab
⚠️ Moderate Risk
FEI: 3005798983 • Taichung City • TAIWAN
FEI Number
3005798983
Location
Taichung City
Country
TAIWANAddress
Kung-Hsueh Rd Rm3, , Taichung City, , Taiwan
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).
Refusal History
Frequently Asked Questions
What is Jupiter Ortho Lab's FDA import refusal history?
Jupiter Ortho Lab (FEI: 3005798983) has 2 FDA import refusal record(s) in our database, spanning from 10/11/2006 to 10/11/2006.
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. Jupiter Ortho Lab's FEI number is 3005798983.
What types of violations has Jupiter Ortho Lab received?
Jupiter Ortho Lab has been cited for 1 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 Jupiter Ortho Lab come from?
All FDA import refusal data for Jupiter Ortho Lab 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.