Focal Vision International Pvt Ltd
⚠️ Moderate Risk
FEI: 3003417402 • Mumbai, Maharashtra • INDIA
FEI Number
3003417402
Location
Mumbai, Maharashtra
Country
INDIAAddress
6 Om Satyam Niwas, , Mumbai, Maharashtra, 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
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).
NO PMA/PDP
The article appears to be a class III dev.w/o an approved applic. for premarket approval, and/or a notice of completion of product development protocol filed per section 515(b) or exempt per sect.520(g)(1).
Refusal History
Frequently Asked Questions
What is Focal Vision International Pvt Ltd's FDA import refusal history?
Focal Vision International Pvt Ltd (FEI: 3003417402) has 1 FDA import refusal record(s) in our database, spanning from 1/14/2002 to 1/14/2002.
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. Focal Vision International Pvt Ltd's FEI number is 3003417402.
What types of violations has Focal Vision International Pvt Ltd received?
Focal Vision International 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 Focal Vision International Pvt Ltd come from?
All FDA import refusal data for Focal Vision International 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.