Track Of Surgical
⚠️ High Risk
FEI: 3008350177 • Sialkot, Punjab • PAKISTAN
FEI Number
3008350177
Location
Sialkot, Punjab
Country
PAKISTANAddress
Commissioner 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
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).
FAILS STD
The article appears to be a device which is subject to a performance standard established under Section 514 and does not appear to be in all respects in conformity with such standard.
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 6/20/2012 | 85HDQDILATOR, CERVICAL, FIXED SIZE | 290DE IMP GMP | New Orleans District Office (NOL-DO) |
| 6/20/2012 | 85HCYCURETTE, UTERINE | 290DE IMP GMP | New Orleans District Office (NOL-DO) |
| 6/20/2012 | 76EIGRETRACTOR, ALL TYPES | 290DE IMP GMP | New Orleans District Office (NOL-DO) |
| 6/20/2012 | 85HDCTENACULUM, UTERINE | 290DE IMP GMP | New Orleans District Office (NOL-DO) |
| 6/20/2012 | 85HDFSPECULUM, VAGINAL, METAL | 290DE IMP GMP | New Orleans District Office (NOL-DO) |
| 6/20/2012 | 76EMEPUNCH, BIOPSY, SURGICAL | 290DE IMP GMP | New Orleans District Office (NOL-DO) |
| 6/20/2012 | 85HDFSPECULUM, VAGINAL, METAL | 290DE IMP GMP | New Orleans District Office (NOL-DO) |
| 6/20/2012 | 85HDCTENACULUM, UTERINE | 290DE IMP GMP | New Orleans District Office (NOL-DO) |
| 6/20/2012 | 85HDFSPECULUM, VAGINAL, METAL | 290DE IMP GMP | New Orleans District Office (NOL-DO) |
| 6/20/2012 | 85HDFSPECULUM, VAGINAL, METAL | 290DE IMP GMP | New Orleans District Office (NOL-DO) |
| 5/13/2010 | 85HDFSPECULUM, VAGINAL, METAL | 126FAILS STD | New York District Office (NYK-DO) |
| 5/13/2010 | 85HDFSPECULUM, VAGINAL, METAL | 126FAILS STD | New York District Office (NYK-DO) |
| 5/13/2010 | 85HDFSPECULUM, VAGINAL, METAL | 126FAILS STD | New York District Office (NYK-DO) |
| 5/13/2010 | 85HDFSPECULUM, VAGINAL, METAL | 126FAILS STD | New York District Office (NYK-DO) |
| 5/13/2010 | 85HDFSPECULUM, VAGINAL, METAL | 126FAILS STD | New York District Office (NYK-DO) |
| 5/13/2010 | 85HDFSPECULUM, VAGINAL, METAL | 126FAILS STD | New York District Office (NYK-DO) |
| 5/13/2010 | 85HDFSPECULUM, VAGINAL, METAL | 126FAILS STD | New York District Office (NYK-DO) |
| 5/13/2010 | 85HDFSPECULUM, VAGINAL, METAL | 126FAILS STD | New York District Office (NYK-DO) |
| 4/19/2010 | 85HDQDILATOR, CERVICAL, FIXED SIZE | 290DE IMP GMP | Seattle District Office (SEA-DO) |
| 4/19/2010 | 85HDLRETRACTOR, VAGINAL | 290DE IMP GMP | Seattle District Office (SEA-DO) |
| 9/8/2009 | 85HDFSPECULUM, VAGINAL, METAL | 2780DEVICEGMPS | Seattle District Office (SEA-DO) |
| 9/8/2009 | 85HDQDILATOR, CERVICAL, FIXED SIZE | 2780DEVICEGMPS | Seattle District Office (SEA-DO) |
| 9/8/2009 | 85HDFSPECULUM, VAGINAL, METAL | 2780DEVICEGMPS | Seattle District Office (SEA-DO) |
Frequently Asked Questions
What is Track Of Surgical's FDA import refusal history?
Track Of Surgical (FEI: 3008350177) has 23 FDA import refusal record(s) in our database, spanning from 9/8/2009 to 6/20/2012.
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. Track Of Surgical's FEI number is 3008350177.
What types of violations has Track Of Surgical received?
Track Of Surgical 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 Track Of Surgical come from?
All FDA import refusal data for Track Of Surgical 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.