B. Ali Impex
✅ Low Risk
FEI: 3003882387 • Sialkot • PAKISTAN
FEI Number
3003882387
Location
Sialkot
Country
PAKISTANAddress
Khadim Ali Road, Kotli Behram, Sialkot, , Pakistan
Low Risk
FDA Import Risk Assessment
This firm has a minimal history of FDA import refusals with low-severity violations.
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
REGISTERED
It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/28/2017 | 78FBQTROCAR, GASTRO-UROLOGY | 341REGISTERED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is B. Ali Impex's FDA import refusal history?
B. Ali Impex (FEI: 3003882387) has 1 FDA import refusal record(s) in our database, spanning from 12/28/2017 to 12/28/2017.
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. B. Ali Impex's FEI number is 3003882387.
What types of violations has B. Ali Impex received?
B. Ali Impex 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 B. Ali Impex come from?
All FDA import refusal data for B. Ali Impex 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.