Faizan Surgical
⚠️ High Risk
FEI: 3008684204 • Sialkot, Punjab • PAKISTAN
FEI Number
3008684204
Location
Sialkot, Punjab
Country
PAKISTANAddress
Small Industrial Estate, , Sialkot, Punjab, Pakistan
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable 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
DE IMP GMP
The article is subject to refusal of admission pursuant to section 801(a)(1) in that it appears that the methods used in, or the facilities or controls used for, the manufacture of the device do not conform to the applicable requirements of section 520(f).
LACKS FIRM
The article is in package form and appears to not bear a label containing the name and place of business of the manufacturer, packer, or distributor.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 1/6/2012 | 79MDMINSTRUMENT, MANUAL, GENERAL SURGICAL | 333LACKS FIRM | New Orleans District Office (NOL-DO) |
| 8/29/2011 | 79GDGHOOK, SURGICAL, GENERAL & PLASTIC SURGERY | 290DE IMP GMP | New Orleans District Office (NOL-DO) |
| 8/29/2011 | 79HTDFORCEPS | 290DE IMP GMP | New Orleans District Office (NOL-DO) |
| 8/29/2011 | 77KBNGAG, MOUTH | 290DE IMP GMP | New Orleans District Office (NOL-DO) |
| 8/29/2011 | 79GADRETRACTOR, SURGICAL, GENERAL & PLASTIC SURGERY | 290DE IMP GMP | New Orleans District Office (NOL-DO) |
| 8/29/2011 | 79GFJMALLET, SURGICAL, GENERAL & PLASTIC SURGERY | 290DE IMP GMP | New Orleans District Office (NOL-DO) |
| 8/29/2011 | 79HXDCLAMP | 290DE IMP GMP | New Orleans District Office (NOL-DO) |
| 8/29/2011 | 76EMKCURETTE, SURGICAL, DENTAL | 290DE IMP GMP | New Orleans District Office (NOL-DO) |
| 8/29/2011 | 79GAESNARE, SURGICAL | 290DE IMP GMP | New Orleans District Office (NOL-DO) |
| 8/29/2011 | 77JYTPICK, MICROSURGICAL EAR | 290DE IMP GMP | New Orleans District Office (NOL-DO) |
| 8/29/2011 | 85HDFSPECULUM, VAGINAL, METAL | 290DE IMP GMP | New Orleans District Office (NOL-DO) |
| 8/29/2011 | 79HWMOSTEOTOME | 290DE IMP GMP | New Orleans District Office (NOL-DO) |
| 8/29/2011 | 77JZFTUBE, EAR SUCTION | 290DE IMP GMP | New Orleans District Office (NOL-DO) |
| 8/29/2011 | 79HTEELEVATOR | 290DE IMP GMP | New Orleans District Office (NOL-DO) |
| 8/29/2011 | 79GDIDISSECTOR, SURGICAL, GENERAL & PLASTIC SURGERY | 290DE IMP GMP | New Orleans District Office (NOL-DO) |
| 8/29/2011 | 79GDGHOOK, SURGICAL, GENERAL & PLASTIC SURGERY | 290DE IMP GMP | New Orleans District Office (NOL-DO) |
| 8/29/2011 | 79GADRETRACTOR, SURGICAL, GENERAL & PLASTIC SURGERY | 290DE IMP GMP | New Orleans District Office (NOL-DO) |
| 8/29/2011 | 87HXBPROBE | 290DE IMP GMP | New Orleans District Office (NOL-DO) |
| 8/29/2011 | 79GCCDILATOR, CATHETER | 290DE IMP GMP | New Orleans District Office (NOL-DO) |
| 8/29/2011 | 79GDZHANDLE, SCALPEL | 290DE IMP GMP | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Faizan Surgical's FDA import refusal history?
Faizan Surgical (FEI: 3008684204) has 20 FDA import refusal record(s) in our database, spanning from 8/29/2011 to 1/6/2012.
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. Faizan Surgical's FEI number is 3008684204.
What types of violations has Faizan Surgical received?
Faizan Surgical has been cited for 2 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 Faizan Surgical come from?
All FDA import refusal data for Faizan 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.