FRANKO SHEHZAD SURGICO LTD.
⚠️ Moderate Risk
FEI: 3007389672 • Sialkot, Punjab • PAKISTAN
FEI Number
3007389672
Location
Sialkot, Punjab
Country
PAKISTANAddress
2C 4 C 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
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).
HOLES
The quality of the article falls below that which it purports or is represented to possess, in that the devices contain defects/holes.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 7/9/2011 | 79HTDFORCEPS | 477HOLES | New York District Office (NYK-DO) |
| 4/5/2011 | 79LRWSCISSORS, GENERAL USE, SURGICAL | 290DE IMP GMP | New York District Office (NYK-DO) |
| 10/14/2009 | 79GENFORCEPS, GENERAL & PLASTIC SURGERY | 480STAINSTEEL | New York District Office (NYK-DO) |
| 10/14/2009 | 79GENFORCEPS, GENERAL & PLASTIC SURGERY | 480STAINSTEEL | New York District Office (NYK-DO) |
| 5/20/2009 | 87HRRSCISSORS | 480STAINSTEEL | Chicago District Office (CHI-DO) |
| 5/20/2009 | 87HRRSCISSORS | 480STAINSTEEL | Chicago District Office (CHI-DO) |
| 5/20/2009 | 78FHQHOLDER, NEEDLE | 480STAINSTEEL | Chicago District Office (CHI-DO) |
| 5/20/2009 | 79HTDFORCEPS | 480STAINSTEEL | Chicago District Office (CHI-DO) |
| 5/20/2009 | 79HTDFORCEPS | 480STAINSTEEL | Chicago District Office (CHI-DO) |
Frequently Asked Questions
What is FRANKO SHEHZAD SURGICO LTD.'s FDA import refusal history?
FRANKO SHEHZAD SURGICO LTD. (FEI: 3007389672) has 9 FDA import refusal record(s) in our database, spanning from 5/20/2009 to 7/9/2011.
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. FRANKO SHEHZAD SURGICO LTD.'s FEI number is 3007389672.
What types of violations has FRANKO SHEHZAD SURGICO LTD. received?
FRANKO SHEHZAD SURGICO LTD. 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 FRANKO SHEHZAD SURGICO LTD. come from?
All FDA import refusal data for FRANKO SHEHZAD SURGICO 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.