SEASONED SURGICALPRODUCTS
⚠️ High Risk
FEI: 3007774473 • Sialkot, Punjab • PAKISTAN
FEI
FEI Number
3007774473
📍
Location
Sialkot, Punjab
🇵🇰
Country
PAKISTAN🏢
Address
DASKA ROAD, ADDAH, NEAR CHURCH, P.O. Box 1365, Sialkot, Punjab, Pakistan
High Risk
FDA Import Risk Assessment
62.7
LowModerateHighCritical
This firm has a significant history of FDA import refusals with notable violations.
Statistics
72
Total Refusals
2
Unique Violations
9/13/2011
Latest Refusal
9/16/2010
Earliest Refusal
Score Breakdown
Violation Severity
80.0×40%
Refusal Volume
69.0×30%
Recency
0.0×20%
Frequency
100.0×10%
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
48070×
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.
2902×
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 9/13/2011 | 79GAFSPATULA, SURGICAL, GENERAL & PLASTIC SURGERY | 290DE IMP GMP | New York District Office (NYK-DO) |
| 9/13/2011 | 79HTFCURETTE | 290DE IMP GMP | New York District Office (NYK-DO) |
| 1/19/2011 | 79GENFORCEPS, GENERAL & PLASTIC SURGERY | 480STAINSTEEL | New York District Office (NYK-DO) |
| 1/19/2011 | 79GENFORCEPS, GENERAL & PLASTIC SURGERY | 480STAINSTEEL | New York District Office (NYK-DO) |
| 1/19/2011 | 79GENFORCEPS, GENERAL & PLASTIC SURGERY | 480STAINSTEEL | New York District Office (NYK-DO) |
| 1/19/2011 | 79GADRETRACTOR, SURGICAL, GENERAL & PLASTIC SURGERY | 480STAINSTEEL | New York District Office (NYK-DO) |
| 1/19/2011 | 79GENFORCEPS, GENERAL & PLASTIC SURGERY | 480STAINSTEEL | New York District Office (NYK-DO) |
| 1/19/2011 | 79GENFORCEPS, GENERAL & PLASTIC SURGERY | 480STAINSTEEL | New York District Office (NYK-DO) |
| 1/19/2011 | 79GENFORCEPS, GENERAL & PLASTIC SURGERY | 480STAINSTEEL | New York District Office (NYK-DO) |
| 1/19/2011 | 79GENFORCEPS, GENERAL & PLASTIC SURGERY | 480STAINSTEEL | New York District Office (NYK-DO) |
| 1/19/2011 | 79GENFORCEPS, GENERAL & PLASTIC SURGERY | 480STAINSTEEL | New York District Office (NYK-DO) |
| 1/19/2011 | 79GENFORCEPS, GENERAL & PLASTIC SURGERY | 480STAINSTEEL | New York District Office (NYK-DO) |
| 1/19/2011 | 79GENFORCEPS, GENERAL & PLASTIC SURGERY | 480STAINSTEEL | New York District Office (NYK-DO) |
| 1/18/2011 | 79GENFORCEPS, GENERAL & PLASTIC SURGERY | 480STAINSTEEL | New York District Office (NYK-DO) |
| 1/18/2011 | 79GENFORCEPS, GENERAL & PLASTIC SURGERY | 480STAINSTEEL | New York District Office (NYK-DO) |
| 1/18/2011 | 79GENFORCEPS, GENERAL & PLASTIC SURGERY | 480STAINSTEEL | New York District Office (NYK-DO) |
| 1/18/2011 | 79GENFORCEPS, GENERAL & PLASTIC SURGERY | 480STAINSTEEL | New York District Office (NYK-DO) |
| 1/18/2011 | 79GENFORCEPS, GENERAL & PLASTIC SURGERY | 480STAINSTEEL | New York District Office (NYK-DO) |
| 1/18/2011 | 79GENFORCEPS, GENERAL & PLASTIC SURGERY | 480STAINSTEEL | New York District Office (NYK-DO) |
| 1/18/2011 | 79GENFORCEPS, GENERAL & PLASTIC SURGERY | 480STAINSTEEL | New York District Office (NYK-DO) |
| 1/18/2011 | 79GENFORCEPS, GENERAL & PLASTIC SURGERY | 480STAINSTEEL | New York District Office (NYK-DO) |
| 1/18/2011 | 79GENFORCEPS, GENERAL & PLASTIC SURGERY | 480STAINSTEEL | New York District Office (NYK-DO) |
| 1/18/2011 | 79GENFORCEPS, GENERAL & PLASTIC SURGERY | 480STAINSTEEL | New York District Office (NYK-DO) |
| 1/18/2011 | 79GENFORCEPS, GENERAL & PLASTIC SURGERY | 480STAINSTEEL | New York District Office (NYK-DO) |
| 1/18/2011 | 79GENFORCEPS, GENERAL & PLASTIC SURGERY | 480STAINSTEEL | New York District Office (NYK-DO) |
| 1/18/2011 | 79GENFORCEPS, GENERAL & PLASTIC SURGERY | 480STAINSTEEL | New York District Office (NYK-DO) |
| 1/18/2011 | 79GENFORCEPS, GENERAL & PLASTIC SURGERY | 480STAINSTEEL | New York District Office (NYK-DO) |
| 1/18/2011 | 79GENFORCEPS, GENERAL & PLASTIC SURGERY | 480STAINSTEEL | New York District Office (NYK-DO) |
| 1/18/2011 | 79GENFORCEPS, GENERAL & PLASTIC SURGERY | 480STAINSTEEL | New York District Office (NYK-DO) |
| 1/18/2011 | 79GENFORCEPS, GENERAL & PLASTIC SURGERY | 480STAINSTEEL | New York District Office (NYK-DO) |
| 1/18/2011 | 79GENFORCEPS, GENERAL & PLASTIC SURGERY | 480STAINSTEEL | New York District Office (NYK-DO) |
| 1/18/2011 | 79GENFORCEPS, GENERAL & PLASTIC SURGERY | 480STAINSTEEL | New York District Office (NYK-DO) |
| 1/18/2011 | 79GENFORCEPS, GENERAL & PLASTIC SURGERY | 480STAINSTEEL | New York District Office (NYK-DO) |
| 1/18/2011 | 79LRWSCISSORS, GENERAL USE, SURGICAL | 480STAINSTEEL | New York District Office (NYK-DO) |
| 1/18/2011 | 79GENFORCEPS, GENERAL & PLASTIC SURGERY | 480STAINSTEEL | New York District Office (NYK-DO) |
| 1/18/2011 | 79GENFORCEPS, GENERAL & PLASTIC SURGERY | 480STAINSTEEL | New York District Office (NYK-DO) |
| 1/18/2011 | 79GENFORCEPS, GENERAL & PLASTIC SURGERY | 480STAINSTEEL | New York District Office (NYK-DO) |
| 1/18/2011 | 79GENFORCEPS, GENERAL & PLASTIC SURGERY | 480STAINSTEEL | New York District Office (NYK-DO) |
| 1/18/2011 | 79GENFORCEPS, GENERAL & PLASTIC SURGERY | 480STAINSTEEL | New York District Office (NYK-DO) |
| 1/18/2011 | 79GENFORCEPS, GENERAL & PLASTIC SURGERY | 480STAINSTEEL | New York District Office (NYK-DO) |
| 1/18/2011 | 79EMFKNIFE, SURGICAL | 480STAINSTEEL | New York District Office (NYK-DO) |
| 1/18/2011 | 79GENFORCEPS, GENERAL & PLASTIC SURGERY | 480STAINSTEEL | New York District Office (NYK-DO) |
| 1/18/2011 | 79GDJCLAMP, SURGICAL, GENERAL & PLASTIC SURGERY | 480STAINSTEEL | New York District Office (NYK-DO) |
| 1/18/2011 | 79GADRETRACTOR, SURGICAL, GENERAL & PLASTIC SURGERY | 480STAINSTEEL | New York District Office (NYK-DO) |
| 1/7/2011 | 79GENFORCEPS, GENERAL & PLASTIC SURGERY | 480STAINSTEEL | New York District Office (NYK-DO) |
| 1/7/2011 | 79GDIDISSECTOR, SURGICAL, GENERAL & PLASTIC SURGERY | 480STAINSTEEL | New York District Office (NYK-DO) |
| 1/7/2011 | 79GADRETRACTOR, SURGICAL, GENERAL & PLASTIC SURGERY | 480STAINSTEEL | New York District Office (NYK-DO) |
| 1/7/2011 | 79GENFORCEPS, GENERAL & PLASTIC SURGERY | 480STAINSTEEL | New York District Office (NYK-DO) |
| 12/22/2010 | 79GDJCLAMP, SURGICAL, GENERAL & PLASTIC SURGERY | 480STAINSTEEL | New York District Office (NYK-DO) |
| 12/22/2010 | 79GENFORCEPS, GENERAL & PLASTIC SURGERY | 480STAINSTEEL | New York District Office (NYK-DO) |
| 12/22/2010 | 79GENFORCEPS, GENERAL & PLASTIC SURGERY | 480STAINSTEEL | New York District Office (NYK-DO) |
| 12/22/2010 | 79GENFORCEPS, GENERAL & PLASTIC SURGERY | 480STAINSTEEL | New York District Office (NYK-DO) |
| 12/22/2010 | 79GENFORCEPS, GENERAL & PLASTIC SURGERY | 480STAINSTEEL | New York District Office (NYK-DO) |
| 12/22/2010 | 79GENFORCEPS, GENERAL & PLASTIC SURGERY | 480STAINSTEEL | New York District Office (NYK-DO) |
| 12/22/2010 | 79GENFORCEPS, GENERAL & PLASTIC SURGERY | 480STAINSTEEL | New York District Office (NYK-DO) |
| 12/22/2010 | 79GDFGUIDE, NEEDLE, SURGICAL | 480STAINSTEEL | New York District Office (NYK-DO) |
| 12/22/2010 | 79LRWSCISSORS, GENERAL USE, SURGICAL | 480STAINSTEEL | New York District Office (NYK-DO) |
| 12/22/2010 | 79GENFORCEPS, GENERAL & PLASTIC SURGERY | 480STAINSTEEL | New York District Office (NYK-DO) |
| 12/22/2010 | 79GADRETRACTOR, SURGICAL, GENERAL & PLASTIC SURGERY | 480STAINSTEEL | New York District Office (NYK-DO) |
| 12/22/2010 | 79EMFKNIFE, SURGICAL | 480STAINSTEEL | New York District Office (NYK-DO) |
| 12/22/2010 | 79GENFORCEPS, GENERAL & PLASTIC SURGERY | 480STAINSTEEL | New York District Office (NYK-DO) |
| 9/22/2010 | 79GENFORCEPS, GENERAL & PLASTIC SURGERY | 480STAINSTEEL | New York District Office (NYK-DO) |
| 9/22/2010 | 79GDFGUIDE, NEEDLE, SURGICAL | 480STAINSTEEL | New York District Office (NYK-DO) |
| 9/22/2010 | 79GENFORCEPS, GENERAL & PLASTIC SURGERY | 480STAINSTEEL | New York District Office (NYK-DO) |
| 9/22/2010 | 79LRWSCISSORS, GENERAL USE, SURGICAL | 480STAINSTEEL | New York District Office (NYK-DO) |
| 9/22/2010 | 79GENFORCEPS, GENERAL & PLASTIC SURGERY | 480STAINSTEEL | New York District Office (NYK-DO) |
| 9/22/2010 | 79GADRETRACTOR, SURGICAL, GENERAL & PLASTIC SURGERY | 480STAINSTEEL | New York District Office (NYK-DO) |
| 9/22/2010 | 79GENFORCEPS, GENERAL & PLASTIC SURGERY | 480STAINSTEEL | New York District Office (NYK-DO) |
| 9/22/2010 | 79GENFORCEPS, GENERAL & PLASTIC SURGERY | 480STAINSTEEL | New York District Office (NYK-DO) |
| 9/22/2010 | 79GENFORCEPS, GENERAL & PLASTIC SURGERY | 480STAINSTEEL | New York District Office (NYK-DO) |
| 9/16/2010 | 79EMFKNIFE, SURGICAL | 480STAINSTEEL | New York District Office (NYK-DO) |
| 9/16/2010 | 79GENFORCEPS, GENERAL & PLASTIC SURGERY | 480STAINSTEEL | New York District Office (NYK-DO) |
Frequently Asked Questions
What is SEASONED SURGICALPRODUCTS's FDA import refusal history?
SEASONED SURGICALPRODUCTS (FEI: 3007774473) has 72 FDA import refusal record(s) in our database, spanning from 9/16/2010 to 9/13/2011.
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. SEASONED SURGICALPRODUCTS's FEI number is 3007774473.
What types of violations has SEASONED SURGICALPRODUCTS received?
SEASONED SURGICALPRODUCTS 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 SEASONED SURGICALPRODUCTS come from?
All FDA import refusal data for SEASONED SURGICALPRODUCTS 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.