HEALTHIUM MED TECH PVT LTD
⚠️ Moderate Risk
FEI: 3014299871 • Bangalore, Karnataka • INDIA
FEI Number
3014299871
Location
Bangalore, Karnataka
Country
INDIAAddress
472 - D 13'Th Cross Road, , Bangalore, Karnataka, India
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
FALSE
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose labeling appears to be false or misleading.
RX DEVICE
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a prescription device that appears to not feature a prescription device legend as required by 21 CFR 801.109.
Refusal History
Frequently Asked Questions
What is HEALTHIUM MED TECH PVT LTD's FDA import refusal history?
HEALTHIUM MED TECH PVT LTD (FEI: 3014299871) has 1 FDA import refusal record(s) in our database, spanning from 5/21/2018 to 5/21/2018.
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. HEALTHIUM MED TECH PVT LTD's FEI number is 3014299871.
What types of violations has HEALTHIUM MED TECH PVT LTD received?
HEALTHIUM MED TECH PVT 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 HEALTHIUM MED TECH PVT LTD come from?
All FDA import refusal data for HEALTHIUM MED TECH PVT 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.