Surgicon (Pvt) Limited
⚠️ High Risk
FEI: 1000347621 • Sialkot, Punjab • PAKISTAN
FEI Number
1000347621
Location
Sialkot, Punjab
Country
PAKISTANAddress
Starmed Engineering, PO Box 244 Khadim Ali Road, 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
DEVICEGMPS
The article is subject to refusal of admission pursuant to Section 801(a)(1) in that the methods used in, or the facilities or controls used for, the manufacture, packing, storage, or installation of the device do not conform to the requirements of Section 520(f)(1) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) or a condition prescribed by an order under section 520(f)(2) of the FD&C Act.
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.
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).
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 |
|---|---|---|---|
| 7/23/2012 | 77KADELEVATOR, ENT | 290DE IMP GMP | Cincinnati District Office (CIN-DO) |
| 7/23/2012 | 77KAEFORCEPS, ENT | 290DE IMP GMP | Cincinnati District Office (CIN-DO) |
| 7/23/2012 | 77KALRETRACTOR, ENT | 290DE IMP GMP | Cincinnati District Office (CIN-DO) |
| 7/23/2012 | 77KAEFORCEPS, ENT | 290DE IMP GMP | Cincinnati District Office (CIN-DO) |
| 7/23/2012 | 78FHQHOLDER, NEEDLE | 290DE IMP GMP | Cincinnati District Office (CIN-DO) |
| 7/23/2012 | 79GDZHANDLE, SCALPEL | 290DE IMP GMP | Cincinnati District Office (CIN-DO) |
| 7/23/2012 | 86HNCSPECULA, OPHTHALMIC | 290DE IMP GMP | Cincinnati District Office (CIN-DO) |
| 6/5/2012 | 79GENFORCEPS, GENERAL & PLASTIC SURGERY | 2780DEVICEGMPS | New York District Office (NYK-DO) |
| 6/5/2012 | 79GENFORCEPS, GENERAL & PLASTIC SURGERY | 2780DEVICEGMPS | New York District Office (NYK-DO) |
| 6/5/2012 | 79LRWSCISSORS, GENERAL USE, SURGICAL | 2780DEVICEGMPS | New York District Office (NYK-DO) |
| 8/1/2011 | 73CCWLARYNGOSCOPE, RIGID | New York District Office (NYK-DO) | |
| 5/26/2011 | 73CCWLARYNGOSCOPE, RIGID | 480STAINSTEEL | New York District Office (NYK-DO) |
| 5/9/2011 | 73CCWLARYNGOSCOPE, RIGID | 2780DEVICEGMPS | New York District Office (NYK-DO) |
| 4/28/2011 | 73CCWLARYNGOSCOPE, RIGID | 480STAINSTEEL | New York District Office (NYK-DO) |
| 4/28/2011 | 73CCWLARYNGOSCOPE, RIGID | 480STAINSTEEL | New York District Office (NYK-DO) |
| 4/28/2011 | 73CCWLARYNGOSCOPE, RIGID | 480STAINSTEEL | New York District Office (NYK-DO) |
| 3/8/2011 | 73CCWLARYNGOSCOPE, RIGID | 480STAINSTEEL | New York District Office (NYK-DO) |
| 3/8/2011 | 73CCWLARYNGOSCOPE, RIGID | 480STAINSTEEL | New York District Office (NYK-DO) |
| 3/8/2011 | 73CCWLARYNGOSCOPE, RIGID | 480STAINSTEEL | New York District Office (NYK-DO) |
| 3/8/2011 | 73CCWLARYNGOSCOPE, RIGID | 480STAINSTEEL | New York District Office (NYK-DO) |
| 3/8/2011 | 73CCWLARYNGOSCOPE, RIGID | 480STAINSTEEL | New York District Office (NYK-DO) |
| 3/8/2011 | 73CCWLARYNGOSCOPE, RIGID | 480STAINSTEEL | New York District Office (NYK-DO) |
| 3/8/2011 | 73CCWLARYNGOSCOPE, RIGID | 480STAINSTEEL | New York District Office (NYK-DO) |
| 2/3/2011 | 73CCWLARYNGOSCOPE, RIGID | 480STAINSTEEL | New York District Office (NYK-DO) |
| 4/2/2010 | 79LRWSCISSORS, GENERAL USE, SURGICAL | 2780DEVICEGMPS | New York District Office (NYK-DO) |
| 4/2/2010 | 79HTDFORCEPS | 2780DEVICEGMPS | New York District Office (NYK-DO) |
| 4/2/2010 | 79GENFORCEPS, GENERAL & PLASTIC SURGERY | 2780DEVICEGMPS | Division of Northern Border Imports (DNBI) |
| 4/2/2010 | 80JOKSCISSORS, MEDICAL, DISPOSABLE | 2780DEVICEGMPS | Division of Northern Border Imports (DNBI) |
| 4/2/2010 | 79GENFORCEPS, GENERAL & PLASTIC SURGERY | 2780DEVICEGMPS | Division of Northern Border Imports (DNBI) |
| 3/31/2010 | 79GENFORCEPS, GENERAL & PLASTIC SURGERY | 2780DEVICEGMPS | New York District Office (NYK-DO) |
| 3/31/2010 | 79GENFORCEPS, GENERAL & PLASTIC SURGERY | 2780DEVICEGMPS | New York District Office (NYK-DO) |
| 3/31/2010 | 79LRWSCISSORS, GENERAL USE, SURGICAL | 2780DEVICEGMPS | New York District Office (NYK-DO) |
| 7/27/2006 | 79HTDFORCEPS | 2780DEVICEGMPS | Cincinnati District Office (CIN-DO) |
| 12/23/2004 | 87HRRSCISSORS | 480STAINSTEEL | Philadelphia District Office (PHI-DO) |
| 12/21/2004 | 77KCBTUBE, TONSIL SUCTION | 480STAINSTEEL | Philadelphia District Office (PHI-DO) |
| 3/10/2003 | 79MDWINSTRUMENT, MANUAL, SURGICAL, GENERAL USE | 2780DEVICEGMPS | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is Surgicon (Pvt) Limited's FDA import refusal history?
Surgicon (Pvt) Limited (FEI: 1000347621) has 36 FDA import refusal record(s) in our database, spanning from 3/10/2003 to 7/23/2012.
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. Surgicon (Pvt) Limited's FEI number is 1000347621.
What types of violations has Surgicon (Pvt) Limited received?
Surgicon (Pvt) Limited has been cited for 4 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 Surgicon (Pvt) Limited come from?
All FDA import refusal data for Surgicon (Pvt) Limited 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.