Indo Webal Surgical
⚠️ Moderate Risk
FEI: 3005869073 • West Bengal • INDIA
FEI Number
3005869073
Location
West Bengal
Country
INDIAAddress
Ukilpara Baruipar , Ward - 15, , West Bengal, , 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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 6/4/2012 | 79MDMINSTRUMENT, MANUAL, GENERAL SURGICAL | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 6/4/2012 | 79GENFORCEPS, GENERAL & PLASTIC SURGERY | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 6/4/2012 | 79LRWSCISSORS, GENERAL USE, SURGICAL | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 6/4/2012 | 79HXMRETRACTOR | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 6/4/2012 | 79GFABLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 6/4/2012 | 79GEACANNULA, SURGICAL, GENERAL & PLASTIC SURGERY | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 6/4/2012 | 79EMFKNIFE, SURGICAL | 118NOT LISTED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Indo Webal Surgical's FDA import refusal history?
Indo Webal Surgical (FEI: 3005869073) has 7 FDA import refusal record(s) in our database, spanning from 6/4/2012 to 6/4/2012.
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. Indo Webal Surgical's FEI number is 3005869073.
What types of violations has Indo Webal Surgical received?
Indo Webal Surgical 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 Indo Webal Surgical come from?
All FDA import refusal data for Indo Webal Surgical 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.