Stone Instruments Company
⚠️ Moderate Risk
FEI: 3002802903 • Sialkot, Punjab • PAKISTAN
FEI Number
3002802903
Location
Sialkot, Punjab
Country
PAKISTANAddress
Commissioner Road, Muhammad Pura, , 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.
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.
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).
REGISTERED
It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 3/25/2011 | 79LRWSCISSORS, GENERAL USE, SURGICAL | 480STAINSTEEL | Chicago District Office (CHI-DO) |
| 3/25/2011 | 79LRWSCISSORS, GENERAL USE, SURGICAL | 480STAINSTEEL | Chicago District Office (CHI-DO) |
| 2/1/2011 | 79HTDFORCEPS | 290DE IMP GMP | New York District Office (NYK-DO) |
| 2/1/2011 | 78FHQHOLDER, NEEDLE | 290DE IMP GMP | New York District Office (NYK-DO) |
| 2/1/2011 | 87HRRSCISSORS | 290DE IMP GMP | New York District Office (NYK-DO) |
| 2/1/2011 | 76JEXPLIER, ORTHODONTIC | 290DE IMP GMP | New York District Office (NYK-DO) |
| 5/13/2008 | 87HXBPROBE | 290DE IMP GMP | Cincinnati District Office (CIN-DO) |
| 5/13/2008 | 87HWJAWL | 290DE IMP GMP | Cincinnati District Office (CIN-DO) |
| 5/13/2008 | 87HXXSCREWDRIVER | 290DE IMP GMP | Cincinnati District Office (CIN-DO) |
| 1/18/2008 | 84HBGDRILLS, BURRS, TREPHINES & ACCESSORIES (MANUAL) | 480STAINSTEEL | New York District Office (NYK-DO) |
| 1/18/2008 | 87HTGPROSTHESIS, KNEE, HEMI-, PATELLAR RESURFACING, UNCEMENTED | 480STAINSTEEL | New York District Office (NYK-DO) |
| 1/18/2008 | 87HXXSCREWDRIVER | 480STAINSTEEL | New York District Office (NYK-DO) |
| 1/18/2008 | 87LXIGUIDE, DRILL, LIGAMENT | 480STAINSTEEL | New York District Office (NYK-DO) |
| 1/18/2008 | 87HXWBENDER | 480STAINSTEEL | New York District Office (NYK-DO) |
| 11/9/2007 | 85KOHINSTRUMENT, MANUAL, GENERAL OBSTETRIC-GYNECOLOGIC | 480STAINSTEEL | New York District Office (NYK-DO) |
| 11/9/2007 | 85KOHINSTRUMENT, MANUAL, GENERAL OBSTETRIC-GYNECOLOGIC | 480STAINSTEEL | New York District Office (NYK-DO) |
| 11/9/2007 | 79HTDFORCEPS | 480STAINSTEEL | New York District Office (NYK-DO) |
| 7/25/2007 | 76EMGFORCEPS, TOOTH EXTRACTOR, SURGICAL | 480STAINSTEEL | New York District Office (NYK-DO) |
| 7/23/2007 | 78FHQHOLDER, NEEDLE | 2780DEVICEGMPS | Cincinnati District Office (CIN-DO) |
| 4/21/2006 | 76EMGFORCEPS, TOOTH EXTRACTOR, SURGICAL | 2780DEVICEGMPS | Cincinnati District Office (CIN-DO) |
| 1/6/2006 | 79LRWSCISSORS, GENERAL USE, SURGICAL | 2780DEVICEGMPS | Cincinnati District Office (CIN-DO) |
| 1/6/2006 | 78FHQHOLDER, NEEDLE | 2780DEVICEGMPS | Cincinnati District Office (CIN-DO) |
| 1/6/2006 | 76EMGFORCEPS, TOOTH EXTRACTOR, SURGICAL | 2780DEVICEGMPS | Cincinnati District Office (CIN-DO) |
| 12/2/2005 | 79GENFORCEPS, GENERAL & PLASTIC SURGERY | 2780DEVICEGMPS | Cincinnati District Office (CIN-DO) |
| 12/2/2005 | 79LRWSCISSORS, GENERAL USE, SURGICAL | 2780DEVICEGMPS | Cincinnati District Office (CIN-DO) |
| 12/2/2005 | 78FHQHOLDER, NEEDLE | 2780DEVICEGMPS | Cincinnati District Office (CIN-DO) |
| 9/9/2004 | 79LRWSCISSORS, GENERAL USE, SURGICAL | 2780DEVICEGMPS | Cincinnati District Office (CIN-DO) |
| 9/9/2004 | 79GENFORCEPS, GENERAL & PLASTIC SURGERY | 2780DEVICEGMPS | Cincinnati District Office (CIN-DO) |
| 2/25/2004 | 79LRWSCISSORS, GENERAL USE, SURGICAL | New York District Office (NYK-DO) | |
| 2/25/2004 | 76ECBUNIT, SYRINGE, AIR AND/OR WATER | New York District Office (NYK-DO) | |
| 2/25/2004 | 76EMQHOE, PERIODONTIC | New York District Office (NYK-DO) | |
| 2/25/2004 | 76EFLFORCEPS, DRESSING, DENTAL | New York District Office (NYK-DO) | |
| 2/25/2004 | 76EMJELEVATOR, SURGICAL, DENTAL | New York District Office (NYK-DO) | |
| 2/25/2004 | 76ELAINSTRUMENT, HAND, CALCULUS REMOVAL | New York District Office (NYK-DO) | |
| 2/25/2004 | 76EMGFORCEPS, TOOTH EXTRACTOR, SURGICAL | New York District Office (NYK-DO) | |
| 2/21/2002 | 79HTDFORCEPS | 480STAINSTEEL | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Stone Instruments Company's FDA import refusal history?
Stone Instruments Company (FEI: 3002802903) has 36 FDA import refusal record(s) in our database, spanning from 2/21/2002 to 3/25/2011.
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. Stone Instruments Company's FEI number is 3002802903.
What types of violations has Stone Instruments Company received?
Stone Instruments Company 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 Stone Instruments Company come from?
All FDA import refusal data for Stone Instruments Company 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.