Surgeon Surgical (Pvt) Ltd.
⚠️ Moderate Risk
FEI: 3002808286 • Sialkot, Punjab • PAKISTAN
FEI Number
3002808286
Location
Sialkot, Punjab
Country
PAKISTANAddress
Small Industrial Estate, , Sialkot, Punjab, 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
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).
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 |
|---|---|---|---|
| 8/9/2010 | 79HTDFORCEPS | 290DE IMP GMP | Philadelphia District Office (PHI-DO) |
| 8/9/2010 | 79HTDFORCEPS | 290DE IMP GMP | Philadelphia District Office (PHI-DO) |
| 8/9/2010 | 79LRWSCISSORS, GENERAL USE, SURGICAL | 290DE IMP GMP | Philadelphia District Office (PHI-DO) |
| 3/17/2009 | 79HTDFORCEPS | 480STAINSTEEL | Cincinnati District Office (CIN-DO) |
| 10/21/2005 | 79GENFORCEPS, GENERAL & PLASTIC SURGERY | 480STAINSTEEL | New Orleans District Office (NOL-DO) |
| 6/1/2005 | 79HTDFORCEPS | 290DE IMP GMP | New Orleans District Office (NOL-DO) |
| 6/1/2005 | 79HXDCLAMP | 290DE IMP GMP | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Surgeon Surgical (Pvt) Ltd.'s FDA import refusal history?
Surgeon Surgical (Pvt) Ltd. (FEI: 3002808286) has 7 FDA import refusal record(s) in our database, spanning from 6/1/2005 to 8/9/2010.
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. Surgeon Surgical (Pvt) Ltd.'s FEI number is 3002808286.
What types of violations has Surgeon Surgical (Pvt) Ltd. received?
Surgeon Surgical (Pvt) Ltd. 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 Surgeon Surgical (Pvt) Ltd. come from?
All FDA import refusal data for Surgeon Surgical (Pvt) Ltd. 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.