Mubarik Impex
⚠️ Moderate Risk
FEI: 3005622604 • Silakot • PAKISTAN
FEI Number
3005622604
Location
Silakot
Country
PAKISTANAddress
New Mubarik Pura, , Silakot, , 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
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).
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).
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 |
|---|---|---|---|
| 5/5/2006 | 79GDZHANDLE, SCALPEL | New York District Office (NYK-DO) | |
| 5/5/2006 | 79LRWSCISSORS, GENERAL USE, SURGICAL | New York District Office (NYK-DO) | |
| 5/5/2006 | 80KZHINTRODUCER, SYRINGE NEEDLE | New York District Office (NYK-DO) | |
| 5/5/2006 | 79HTDFORCEPS | New York District Office (NYK-DO) | |
| 5/5/2006 | 79LRYPUNCH, SURGICAL | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Mubarik Impex's FDA import refusal history?
Mubarik Impex (FEI: 3005622604) has 5 FDA import refusal record(s) in our database, spanning from 5/5/2006 to 5/5/2006.
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. Mubarik Impex's FEI number is 3005622604.
What types of violations has Mubarik Impex received?
Mubarik Impex has been cited for 3 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 Mubarik Impex come from?
All FDA import refusal data for Mubarik 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.