Liv Medica Equipments Pvt. Ltd.
⚠️ Moderate Risk
FEI: 3005985328 • Chennai • INDIA
FEI Number
3005985328
Location
Chennai
Country
INDIAAddress
B-26, Phase Ii, Zone B, Tambaram, Chennai, , 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
NO 510(K)
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.
Refusal History
Frequently Asked Questions
What is Liv Medica Equipments Pvt. Ltd.'s FDA import refusal history?
Liv Medica Equipments Pvt. Ltd. (FEI: 3005985328) has 2 FDA import refusal record(s) in our database, spanning from 8/20/2008 to 8/20/2008.
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. Liv Medica Equipments Pvt. Ltd.'s FEI number is 3005985328.
What types of violations has Liv Medica Equipments Pvt. Ltd. received?
Liv Medica Equipments Pvt. Ltd. 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 Liv Medica Equipments Pvt. Ltd. come from?
All FDA import refusal data for Liv Medica Equipments 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.