Major Surgical & Engineering Wor
⚠️ Moderate Risk
FEI: 3005680218 • New Delhi, Delhi • INDIA
FEI Number
3005680218
Location
New Delhi, Delhi
Country
INDIAAddress
2nd Floor, E 3, New Delhi, Delhi, 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 |
|---|---|---|---|
| 3/3/2009 | 86HNRFORCEPS, OPHTHALMIC | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 7/10/2006 | 79GDZHANDLE, SCALPEL | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 7/10/2006 | 86MXYCANNULA, OPHTHALMIC, POSTERIOR CAPSULAR POLISHING, POLYVINYL ACETAL | 118NOT LISTED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Major Surgical & Engineering Wor's FDA import refusal history?
Major Surgical & Engineering Wor (FEI: 3005680218) has 3 FDA import refusal record(s) in our database, spanning from 7/10/2006 to 3/3/2009.
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. Major Surgical & Engineering Wor's FEI number is 3005680218.
What types of violations has Major Surgical & Engineering Wor received?
Major Surgical & Engineering Wor 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 Major Surgical & Engineering Wor come from?
All FDA import refusal data for Major Surgical & Engineering Wor 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.