Leader Brothers Pvt Ltd
⚠️ Moderate Risk
FEI: 3003963789 • Sialkot • PAKISTAN
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
STAINSTEEL
The article appears to be a device whose quality falls below that which it purports or is represented to possess, in that instrument is represented as stainless steel but does not meet requirements for such steel for surgical instruments.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 7/7/2003 | 85HDFSPECULUM, VAGINAL, METAL | 480STAINSTEEL | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Leader Brothers Pvt Ltd's FDA import refusal history?
Leader Brothers Pvt Ltd (FEI: 3003963789) has 1 FDA import refusal record(s) in our database, spanning from 7/7/2003 to 7/7/2003.
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. Leader Brothers Pvt Ltd's FEI number is 3003963789.
What types of violations has Leader Brothers Pvt Ltd received?
Leader Brothers 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 Leader Brothers Pvt Ltd come from?
All FDA import refusal data for Leader Brothers 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.