Best Deals
⚠️ High Risk
FEI: 3008146023 • Sialkot, Punjab • PAKISTAN
FEI Number
3008146023
Location
Sialkot, Punjab
Country
PAKISTANAddress
1-Km-Head Marala Road, , Sialkot, Punjab, 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
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.
DV QUALITY
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be adulterated since its strength differs from, or its purity or quality falls below, that which it purports or is represented to possess.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 4/20/2016 | 79KDDKIT, SURGICAL INSTRUMENT, DISPOSABLE | 2780DEVICEGMPS | Los Angeles District Office (LOS-DO) |
| 4/20/2016 | 77KCPSYRINGE, ENT | 2780DEVICEGMPS | Los Angeles District Office (LOS-DO) |
| 4/20/2016 | 79KDDKIT, SURGICAL INSTRUMENT, DISPOSABLE | 2780DEVICEGMPS | Los Angeles District Office (LOS-DO) |
| 4/20/2016 | 79HTDFORCEPS | 2780DEVICEGMPS | Los Angeles District Office (LOS-DO) |
| 4/20/2016 | 77JZFTUBE, EAR SUCTION | 2780DEVICEGMPS | Los Angeles District Office (LOS-DO) |
| 4/20/2016 | 76EMHFORCEPS, RONGEUR, SURGICAL | 2780DEVICEGMPS | Los Angeles District Office (LOS-DO) |
| 4/20/2016 | 79HTZINSTRUMENT, CUTTING, ORTHOPEDIC | 2780DEVICEGMPS | Los Angeles District Office (LOS-DO) |
| 4/20/2016 | 87HTSKNIFE, ORTHOPEDIC | 2780DEVICEGMPS | Los Angeles District Office (LOS-DO) |
| 4/20/2016 | 77KAEFORCEPS, ENT | 2780DEVICEGMPS | Los Angeles District Office (LOS-DO) |
| 4/20/2016 | 79LRWSCISSORS, GENERAL USE, SURGICAL | 2780DEVICEGMPS | Los Angeles District Office (LOS-DO) |
| 4/20/2016 | 85HDFSPECULUM, VAGINAL, METAL | 2780DEVICEGMPS | Los Angeles District Office (LOS-DO) |
| 4/20/2016 | 73CCWLARYNGOSCOPE, RIGID | 2780DEVICEGMPS | Los Angeles District Office (LOS-DO) |
| 4/20/2016 | 73CCWLARYNGOSCOPE, RIGID | 2780DEVICEGMPS | Los Angeles District Office (LOS-DO) |
| 4/20/2016 | 73CCWLARYNGOSCOPE, RIGID | 2780DEVICEGMPS | Los Angeles District Office (LOS-DO) |
| 4/20/2016 | 73CCWLARYNGOSCOPE, RIGID | 2780DEVICEGMPS | Los Angeles District Office (LOS-DO) |
| 4/20/2016 | 73CCWLARYNGOSCOPE, RIGID | 2780DEVICEGMPS | Los Angeles District Office (LOS-DO) |
| 12/30/2015 | 79HTDFORCEPS | 479DV QUALITY | Los Angeles District Office (LOS-DO) |
| 12/30/2015 | 79HTDFORCEPS | 479DV QUALITY | Los Angeles District Office (LOS-DO) |
| 8/11/2010 | 87LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 480STAINSTEEL | New York District Office (NYK-DO) |
| 8/11/2010 | 79HTFCURETTE | 480STAINSTEEL | New York District Office (NYK-DO) |
| 8/11/2010 | 85HDQDILATOR, CERVICAL, FIXED SIZE | 480STAINSTEEL | New York District Office (NYK-DO) |
| 8/11/2010 | 79GDIDISSECTOR, SURGICAL, GENERAL & PLASTIC SURGERY | 480STAINSTEEL | New York District Office (NYK-DO) |
| 8/11/2010 | 79GDGHOOK, SURGICAL, GENERAL & PLASTIC SURGERY | 480STAINSTEEL | New York District Office (NYK-DO) |
| 8/11/2010 | 77KBXSCREW, TONSIL | 480STAINSTEEL | New York District Office (NYK-DO) |
| 8/11/2010 | 79HWMOSTEOTOME | 480STAINSTEEL | New York District Office (NYK-DO) |
| 8/11/2010 | 77KASKNIFE, NASAL | 480STAINSTEEL | New York District Office (NYK-DO) |
| 8/11/2010 | 79EPYSPECULUM, ENT | 480STAINSTEEL | New York District Office (NYK-DO) |
| 8/11/2010 | 80JOLCATHETER AND TIP, SUCTION | 480STAINSTEEL | New York District Office (NYK-DO) |
| 8/11/2010 | 79MDMINSTRUMENT, MANUAL, GENERAL SURGICAL | 480STAINSTEEL | New York District Office (NYK-DO) |
| 8/11/2010 | 79HTDFORCEPS | 480STAINSTEEL | New York District Office (NYK-DO) |
| 8/11/2010 | 79LRWSCISSORS, GENERAL USE, SURGICAL | 480STAINSTEEL | New York District Office (NYK-DO) |
| 8/11/2010 | 79GDWSTAPLE, IMPLANTABLE | 480STAINSTEEL | New York District Office (NYK-DO) |
| 8/11/2010 | 77KBNGAG, MOUTH | 480STAINSTEEL | New York District Office (NYK-DO) |
| 8/11/2010 | 85HDTDEVICE, INTRAUTERINE, CONTRACEPTIVE AND INTRODUCER | 480STAINSTEEL | New York District Office (NYK-DO) |
| 8/11/2010 | 79GFIOSTEOTOME, MANUAL | 480STAINSTEEL | New York District Office (NYK-DO) |
| 8/11/2010 | 79FZSCURETTE, SURGICAL | 480STAINSTEEL | New York District Office (NYK-DO) |
| 8/11/2010 | 79GEGELEVATOR, SURGICAL, GENERAL & PLASTIC SURGERY | 480STAINSTEEL | New York District Office (NYK-DO) |
| 8/11/2010 | 79GADRETRACTOR, SURGICAL, GENERAL & PLASTIC SURGERY | 480STAINSTEEL | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Best Deals's FDA import refusal history?
Best Deals (FEI: 3008146023) has 38 FDA import refusal record(s) in our database, spanning from 8/11/2010 to 4/20/2016.
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. Best Deals's FEI number is 3008146023.
What types of violations has Best Deals received?
Best Deals 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 Best Deals come from?
All FDA import refusal data for Best Deals 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.