K Plus International
⚠️ High Risk
FEI: 3004429664 • Sialkot • PAKISTAN
FEI Number
3004429664
Location
Sialkot
Country
PAKISTANAddress
12/303 Rana Town,, Adalat Garh Purana, Sialkot, , 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.
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.
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 |
|---|---|---|---|
| 11/30/2010 | 87HRRSCISSORS | 290DE IMP GMP | Division of Southeast Imports (DSEI) |
| 11/30/2010 | 87HXBPROBE | 290DE IMP GMP | Division of Southeast Imports (DSEI) |
| 11/30/2010 | 76DZNMATRIX, DENTAL | 290DE IMP GMP | Division of Southeast Imports (DSEI) |
| 11/30/2010 | 79GAFSPATULA, SURGICAL, GENERAL & PLASTIC SURGERY | 290DE IMP GMP | Division of Southeast Imports (DSEI) |
| 11/30/2010 | 76EIGRETRACTOR, ALL TYPES | 290DE IMP GMP | Division of Southeast Imports (DSEI) |
| 11/30/2010 | 79EMFKNIFE, SURGICAL | 290DE IMP GMP | Division of Southeast Imports (DSEI) |
| 11/30/2010 | 79GAFSPATULA, SURGICAL, GENERAL & PLASTIC SURGERY | 290DE IMP GMP | Division of Southeast Imports (DSEI) |
| 11/30/2010 | 79HXLMALLET | 290DE IMP GMP | Division of Southeast Imports (DSEI) |
| 11/30/2010 | 76EMIFILE, BONE, SURGICAL | 290DE IMP GMP | Division of Southeast Imports (DSEI) |
| 11/30/2010 | 87HTXRONGEUR | 290DE IMP GMP | Division of Southeast Imports (DSEI) |
| 11/30/2010 | 79GECBRUSH, SCRUB, OPERATING-ROOM | 290DE IMP GMP | Division of Southeast Imports (DSEI) |
| 11/30/2010 | 76EAXMIRROR, MOUTH | 290DE IMP GMP | Division of Southeast Imports (DSEI) |
| 11/30/2010 | 76EEFCLAMP, RUBBER DAM | 290DE IMP GMP | Division of Southeast Imports (DSEI) |
| 11/30/2010 | 76EKCEXCAVATOR, DENTAL, OPERATIVE | 290DE IMP GMP | Division of Southeast Imports (DSEI) |
| 11/30/2010 | 76EKBEXPLORER, OPERATIVE | 290DE IMP GMP | Division of Southeast Imports (DSEI) |
| 11/30/2010 | 87KTZCALIPER | 290DE IMP GMP | Division of Southeast Imports (DSEI) |
| 11/30/2010 | 76EIYINSTRUMENT, FILLING, PLASTIC, DENTAL | 290DE IMP GMP | Division of Southeast Imports (DSEI) |
| 11/30/2010 | 76EISREMOVER, CROWN | 290DE IMP GMP | Division of Southeast Imports (DSEI) |
| 11/30/2010 | 76EMJELEVATOR, SURGICAL, DENTAL | 290DE IMP GMP | Division of Southeast Imports (DSEI) |
| 11/30/2010 | 76EKJBURNISHER, OPERATIVE | 290DE IMP GMP | Division of Southeast Imports (DSEI) |
| 11/30/2010 | 76EMNSCALER, PERIODONTIC | 290DE IMP GMP | Division of Southeast Imports (DSEI) |
| 11/30/2010 | 76EKCEXCAVATOR, DENTAL, OPERATIVE | 290DE IMP GMP | Division of Southeast Imports (DSEI) |
| 11/30/2010 | 76EIKCARVER, WAX, DENTAL | 290DE IMP GMP | Division of Southeast Imports (DSEI) |
| 11/30/2010 | 79HTFCURETTE | 290DE IMP GMP | Division of Southeast Imports (DSEI) |
| 11/30/2010 | 76EKHCARVER, DENTAL AMALGAM, OPERATIVE | 290DE IMP GMP | Division of Southeast Imports (DSEI) |
| 11/30/2010 | 79HTDFORCEPS | 290DE IMP GMP | Division of Southeast Imports (DSEI) |
| 11/30/2010 | 79HTCPLIERS, SURGICAL | 290DE IMP GMP | Division of Southeast Imports (DSEI) |
| 2/11/2009 | 76EJISYRINGE, CARTRIDGE | Los Angeles District Office (LOS-DO) | |
| 2/11/2009 | 79GDRSAW, MANUAL AND ACCESSORIES | Los Angeles District Office (LOS-DO) | |
| 2/11/2009 | 76JEXPLIER, ORTHODONTIC | Los Angeles District Office (LOS-DO) | |
| 2/11/2009 | 76EIKCARVER, WAX, DENTAL | Los Angeles District Office (LOS-DO) | |
| 2/11/2009 | 76EJBHANDLE, INSTRUMENT, DENTAL | Los Angeles District Office (LOS-DO) | |
| 2/11/2009 | 77JYRNIPPER, MALLEUS | Los Angeles District Office (LOS-DO) | |
| 2/11/2009 | 79FTYTAPE, MEASURING, RULERS AND CALIPERS | Los Angeles District Office (LOS-DO) | |
| 2/11/2009 | 79GAFSPATULA, SURGICAL, GENERAL & PLASTIC SURGERY | Los Angeles District Office (LOS-DO) | |
| 2/11/2009 | 76EMOKNIFE, PERIODONTIC | Los Angeles District Office (LOS-DO) | |
| 2/11/2009 | 76EIKCARVER, WAX, DENTAL | Los Angeles District Office (LOS-DO) | |
| 2/11/2009 | 76EIYINSTRUMENT, FILLING, PLASTIC, DENTAL | Los Angeles District Office (LOS-DO) | |
| 2/11/2009 | 76EJBHANDLE, INSTRUMENT, DENTAL | Los Angeles District Office (LOS-DO) | |
| 2/11/2009 | 76EMGFORCEPS, TOOTH EXTRACTOR, SURGICAL | Los Angeles District Office (LOS-DO) | |
| 2/11/2009 | 76EIRSCISSORS, COLLAR AND CROWN | Los Angeles District Office (LOS-DO) | |
| 2/6/2009 | 76OFXGENERAL PURPOSE DENTAL TRAY | 2780DEVICEGMPS | Los Angeles District Office (LOS-DO) |
| 2/6/2009 | 76EICSYRINGE, PERIODONTIC, ENDODONTIC, IRRIGATING | 2780DEVICEGMPS | Los Angeles District Office (LOS-DO) |
| 2/6/2009 | 76NXZKIT, DENTAL HYGIENE | 2780DEVICEGMPS | Los Angeles District Office (LOS-DO) |
| 2/6/2009 | 76EIGRETRACTOR, ALL TYPES | 2780DEVICEGMPS | Los Angeles District Office (LOS-DO) |
| 2/6/2009 | 76EIRSCISSORS, COLLAR AND CROWN | 2780DEVICEGMPS | Los Angeles District Office (LOS-DO) |
| 2/6/2009 | 76JEPRETAINER, MATRIX | 2780DEVICEGMPS | Los Angeles District Office (LOS-DO) |
| 2/6/2009 | 76EJEFRAME, RUBBER DAM | 2780DEVICEGMPS | Los Angeles District Office (LOS-DO) |
| 2/6/2009 | 76EGNSCISSORS, SURGICAL TISSUE, DENTAL | 2780DEVICEGMPS | Los Angeles District Office (LOS-DO) |
| 2/6/2009 | 79GAFSPATULA, SURGICAL, GENERAL & PLASTIC SURGERY | 2780DEVICEGMPS | Los Angeles District Office (LOS-DO) |
| 2/6/2009 | 76EIKCARVER, WAX, DENTAL | 2780DEVICEGMPS | Los Angeles District Office (LOS-DO) |
| 2/6/2009 | 76EMSCURETTE, PERIODONTIC | 2780DEVICEGMPS | Los Angeles District Office (LOS-DO) |
| 2/6/2009 | 76EHZEVACUATOR, ORAL CAVITY | 2780DEVICEGMPS | Los Angeles District Office (LOS-DO) |
| 2/6/2009 | 76EKHCARVER, DENTAL AMALGAM, OPERATIVE | 2780DEVICEGMPS | Los Angeles District Office (LOS-DO) |
| 2/6/2009 | 76EIXPROBE, PERIODONTIC | 2780DEVICEGMPS | Los Angeles District Office (LOS-DO) |
| 2/6/2009 | 76EJBHANDLE, INSTRUMENT, DENTAL | 2780DEVICEGMPS | Los Angeles District Office (LOS-DO) |
| 2/6/2009 | 76EJBHANDLE, INSTRUMENT, DENTAL | 2780DEVICEGMPS | Los Angeles District Office (LOS-DO) |
| 2/6/2009 | 76EJBHANDLE, INSTRUMENT, DENTAL | 2780DEVICEGMPS | Los Angeles District Office (LOS-DO) |
| 2/6/2009 | 76EJYPLIERS, OPERATIVE | 2780DEVICEGMPS | Los Angeles District Office (LOS-DO) |
| 2/6/2009 | 76EKDINSTRUMENT, CUTTING, OPERATIVE | 2780DEVICEGMPS | Los Angeles District Office (LOS-DO) |
| 2/6/2009 | 76EMJELEVATOR, SURGICAL, DENTAL | 2780DEVICEGMPS | Los Angeles District Office (LOS-DO) |
| 2/6/2009 | 76EMGFORCEPS, TOOTH EXTRACTOR, SURGICAL | 2780DEVICEGMPS | Los Angeles District Office (LOS-DO) |
| 4/16/2008 | 76EIKCARVER, WAX, DENTAL | 2780DEVICEGMPS | Los Angeles District Office (LOS-DO) |
| 4/16/2008 | 87HTXRONGEUR | 2780DEVICEGMPS | Los Angeles District Office (LOS-DO) |
| 4/16/2008 | 76EKICARRIER, AMALGAM, OPERATIVE | 2780DEVICEGMPS | Los Angeles District Office (LOS-DO) |
| 4/16/2008 | 79FSMTRAY, SURGICAL, INSTRUMENT | 2780DEVICEGMPS | Los Angeles District Office (LOS-DO) |
| 4/16/2008 | 78FHQHOLDER, NEEDLE | 2780DEVICEGMPS | Los Angeles District Office (LOS-DO) |
| 4/16/2008 | 76EKHCARVER, DENTAL AMALGAM, OPERATIVE | 2780DEVICEGMPS | Los Angeles District Office (LOS-DO) |
| 4/16/2008 | 76EIYINSTRUMENT, FILLING, PLASTIC, DENTAL | 2780DEVICEGMPS | Los Angeles District Office (LOS-DO) |
| 4/16/2008 | 76EKBEXPLORER, OPERATIVE | 2780DEVICEGMPS | Los Angeles District Office (LOS-DO) |
| 4/16/2008 | 76EJBHANDLE, INSTRUMENT, DENTAL | 2780DEVICEGMPS | Los Angeles District Office (LOS-DO) |
| 4/16/2008 | 79HTDFORCEPS | 2780DEVICEGMPS | Los Angeles District Office (LOS-DO) |
| 4/16/2008 | 79HTCPLIERS, SURGICAL | 2780DEVICEGMPS | Los Angeles District Office (LOS-DO) |
| 4/16/2008 | 76EJBHANDLE, INSTRUMENT, DENTAL | 2780DEVICEGMPS | Los Angeles District Office (LOS-DO) |
| 4/16/2008 | 76EIKCARVER, WAX, DENTAL | 2780DEVICEGMPS | Los Angeles District Office (LOS-DO) |
| 4/16/2008 | 76EISREMOVER, CROWN | 2780DEVICEGMPS | Los Angeles District Office (LOS-DO) |
| 4/16/2008 | 79HTDFORCEPS | 2780DEVICEGMPS | Los Angeles District Office (LOS-DO) |
| 4/16/2008 | 87KTZCALIPER | 2780DEVICEGMPS | Los Angeles District Office (LOS-DO) |
| 4/16/2008 | 79GAFSPATULA, SURGICAL, GENERAL & PLASTIC SURGERY | 2780DEVICEGMPS | Los Angeles District Office (LOS-DO) |
| 4/16/2008 | 79EMFKNIFE, SURGICAL | 2780DEVICEGMPS | Los Angeles District Office (LOS-DO) |
| 4/16/2008 | 79EMFKNIFE, SURGICAL | 2780DEVICEGMPS | Los Angeles District Office (LOS-DO) |
| 4/16/2008 | 76EMNSCALER, PERIODONTIC | 2780DEVICEGMPS | Los Angeles District Office (LOS-DO) |
| 4/16/2008 | 79HTFCURETTE | 2780DEVICEGMPS | Los Angeles District Office (LOS-DO) |
| 4/16/2008 | 76EIGRETRACTOR, ALL TYPES | 2780DEVICEGMPS | Los Angeles District Office (LOS-DO) |
| 4/16/2008 | 87HXBPROBE | 2780DEVICEGMPS | Los Angeles District Office (LOS-DO) |
| 4/16/2008 | 77KCPSYRINGE, ENT | 2780DEVICEGMPS | Los Angeles District Office (LOS-DO) |
| 4/16/2008 | 78FHQHOLDER, NEEDLE | 2780DEVICEGMPS | Los Angeles District Office (LOS-DO) |
| 4/16/2008 | 87HRRSCISSORS | 2780DEVICEGMPS | Los Angeles District Office (LOS-DO) |
| 4/16/2008 | 76EMJELEVATOR, SURGICAL, DENTAL | 2780DEVICEGMPS | Los Angeles District Office (LOS-DO) |
| 4/16/2008 | 79HTDFORCEPS | 2780DEVICEGMPS | Los Angeles District Office (LOS-DO) |
| 3/5/2005 | 76EMNSCALER, PERIODONTIC | 480STAINSTEEL | Los Angeles District Office (LOS-DO) |
| 3/5/2005 | 76JEXPLIER, ORTHODONTIC | 480STAINSTEEL | Los Angeles District Office (LOS-DO) |
| 3/5/2005 | 76EFLFORCEPS, DRESSING, DENTAL | 480STAINSTEEL | Los Angeles District Office (LOS-DO) |
| 3/5/2005 | 76EMJELEVATOR, SURGICAL, DENTAL | 480STAINSTEEL | Los Angeles District Office (LOS-DO) |
| 3/5/2005 | 76EIKCARVER, WAX, DENTAL | 480STAINSTEEL | Los Angeles District Office (LOS-DO) |
| 12/22/2004 | 76EMGFORCEPS, TOOTH EXTRACTOR, SURGICAL | 341REGISTERED | Los Angeles District Office (LOS-DO) |
| 12/22/2004 | 76EMGFORCEPS, TOOTH EXTRACTOR, SURGICAL | 341REGISTERED | Los Angeles District Office (LOS-DO) |
| 12/22/2004 | 76EMJELEVATOR, SURGICAL, DENTAL | 341REGISTERED | Los Angeles District Office (LOS-DO) |
| 12/22/2004 | 76LYCBONE GRAFTING MATERIAL, SYNTHETIC | 341REGISTERED | Los Angeles District Office (LOS-DO) |
| 12/22/2004 | 76ELAINSTRUMENT, HAND, CALCULUS REMOVAL | 341REGISTERED | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is K Plus International's FDA import refusal history?
K Plus International (FEI: 3004429664) has 117 FDA import refusal record(s) in our database, spanning from 10/15/2001 to 11/30/2010.
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. K Plus International's FEI number is 3004429664.
What types of violations has K Plus International received?
K Plus International 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 K Plus International come from?
All FDA import refusal data for K Plus International 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.