Tinopal Surgical Corp. (Pvt) Ltd.
⚠️ High Risk
FEI: 3002808350 • Sialkot, Punjab • PAKISTAN
FEI Number
3002808350
Location
Sialkot, Punjab
Country
PAKISTANAddress
Unit #-1, 55/57-B; Small Industrial Estate, 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?
- 40% Violation Severity — AI-assessed (1-10)
- 30% Refusal Volume — Logarithmic scale
- 20% Recency — Decays over 5 years
- 10% Frequency — Refusals per year
Violation Summary
NOT LISTED
It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).
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).
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.
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.
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.
DEVICE GMP
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.
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 |
|---|---|---|---|
| 3/14/2017 | 79HTDFORCEPS | 290DE IMP GMP | Division of Southwest Imports (DSWI) |
| 2/6/2017 | 79LRWSCISSORS, GENERAL USE, SURGICAL | 290DE IMP GMP | Division of Southwest Imports (DSWI) |
| 2/6/2017 | 79GENFORCEPS, GENERAL & PLASTIC SURGERY | 290DE IMP GMP | Southwest Import District Office (SWI-DO) |
| 2/6/2017 | 79LRWSCISSORS, GENERAL USE, SURGICAL | 290DE IMP GMP | Southwest Import District Office (SWI-DO) |
| 2/6/2017 | 79HRQHEMOSTAT | 290DE IMP GMP | Southwest Import District Office (SWI-DO) |
| 2/6/2017 | 79LRWSCISSORS, GENERAL USE, SURGICAL | 290DE IMP GMP | Southwest Import District Office (SWI-DO) |
| 2/6/2017 | 79GENFORCEPS, GENERAL & PLASTIC SURGERY | 290DE IMP GMP | Southwest Import District Office (SWI-DO) |
| 2/6/2017 | 79LRWSCISSORS, GENERAL USE, SURGICAL | 290DE IMP GMP | Southwest Import District Office (SWI-DO) |
| 2/6/2017 | 79LRWSCISSORS, GENERAL USE, SURGICAL | 290DE IMP GMP | Southwest Import District Office (SWI-DO) |
| 2/6/2017 | 79LRWSCISSORS, GENERAL USE, SURGICAL | 290DE IMP GMP | Southwest Import District Office (SWI-DO) |
| 2/6/2017 | 79HRQHEMOSTAT | 290DE IMP GMP | Southwest Import District Office (SWI-DO) |
| 2/6/2017 | 79LRWSCISSORS, GENERAL USE, SURGICAL | 290DE IMP GMP | Southwest Import District Office (SWI-DO) |
| 2/6/2017 | 79HRQHEMOSTAT | 290DE IMP GMP | Southwest Import District Office (SWI-DO) |
| 2/6/2017 | 79GENFORCEPS, GENERAL & PLASTIC SURGERY | 290DE IMP GMP | Southwest Import District Office (SWI-DO) |
| 2/6/2017 | 79LRWSCISSORS, GENERAL USE, SURGICAL | 290DE IMP GMP | Southwest Import District Office (SWI-DO) |
| 2/6/2017 | 79GENFORCEPS, GENERAL & PLASTIC SURGERY | 290DE IMP GMP | Southwest Import District Office (SWI-DO) |
| 2/6/2017 | 79LRWSCISSORS, GENERAL USE, SURGICAL | 290DE IMP GMP | Southwest Import District Office (SWI-DO) |
| 2/3/2017 | 86HNRFORCEPS, OPHTHALMIC | 290DE IMP GMP | Southwest Import District Office (SWI-DO) |
| 2/3/2017 | 79LRWSCISSORS, GENERAL USE, SURGICAL | 290DE IMP GMP | Southwest Import District Office (SWI-DO) |
| 2/3/2017 | 79MDMINSTRUMENT, MANUAL, GENERAL SURGICAL | 290DE IMP GMP | Southwest Import District Office (SWI-DO) |
| 1/26/2017 | 86HNRFORCEPS, OPHTHALMIC | 290DE IMP GMP | Southwest Import District Office (SWI-DO) |
| 1/26/2017 | 79GENFORCEPS, GENERAL & PLASTIC SURGERY | 290DE IMP GMP | Southwest Import District Office (SWI-DO) |
| 1/26/2017 | 79HRQHEMOSTAT | 290DE IMP GMP | Southwest Import District Office (SWI-DO) |
| 1/26/2017 | 79HRQHEMOSTAT | 290DE IMP GMP | Southwest Import District Office (SWI-DO) |
| 1/26/2017 | 86HNRFORCEPS, OPHTHALMIC | 290DE IMP GMP | Southwest Import District Office (SWI-DO) |
| 1/26/2017 | 79LRWSCISSORS, GENERAL USE, SURGICAL | 290DE IMP GMP | Southwest Import District Office (SWI-DO) |
| 10/26/2016 | 74DWETUBING, PUMP, CARDIOPULMONARY BYPASS | 290DE IMP GMP | Southwest Import District Office (SWI-DO) |
| 10/18/2016 | 74DWETUBING, PUMP, CARDIOPULMONARY BYPASS | 290DE IMP GMP | Southwest Import District Office (SWI-DO) |
| 9/13/2016 | 79GENFORCEPS, GENERAL & PLASTIC SURGERY | 290DE IMP GMP | Southwest Import District Office (SWI-DO) |
| 9/13/2016 | 79LRWSCISSORS, GENERAL USE, SURGICAL | 290DE IMP GMP | Southwest Import District Office (SWI-DO) |
| 9/13/2016 | 78FHQHOLDER, NEEDLE | 290DE IMP GMP | Southwest Import District Office (SWI-DO) |
| 9/13/2016 | 79LRWSCISSORS, GENERAL USE, SURGICAL | 290DE IMP GMP | Southwest Import District Office (SWI-DO) |
| 9/13/2016 | 79GENFORCEPS, GENERAL & PLASTIC SURGERY | 290DE IMP GMP | Southwest Import District Office (SWI-DO) |
| 9/13/2016 | 79HRQHEMOSTAT | 290DE IMP GMP | Southwest Import District Office (SWI-DO) |
| 9/13/2016 | 78FHQHOLDER, NEEDLE | 290DE IMP GMP | Southwest Import District Office (SWI-DO) |
| 9/13/2016 | 79LRWSCISSORS, GENERAL USE, SURGICAL | 290DE IMP GMP | Southwest Import District Office (SWI-DO) |
| 9/13/2016 | 79GENFORCEPS, GENERAL & PLASTIC SURGERY | 290DE IMP GMP | Southwest Import District Office (SWI-DO) |
| 9/12/2016 | 79LRWSCISSORS, GENERAL USE, SURGICAL | 290DE IMP GMP | Southwest Import District Office (SWI-DO) |
| 9/12/2016 | 79HRQHEMOSTAT | 290DE IMP GMP | Southwest Import District Office (SWI-DO) |
| 9/6/2016 | 79LRWSCISSORS, GENERAL USE, SURGICAL | 290DE IMP GMP | Division of Southwest Imports (DSWI) |
| 9/6/2016 | 78FGMPROBE AND DIRECTOR, GASTRO-UROLOGY | 290DE IMP GMP | Division of Southwest Imports (DSWI) |
| 9/6/2016 | 79HRQHEMOSTAT | 290DE IMP GMP | Division of Southwest Imports (DSWI) |
| 8/29/2016 | 86HNRFORCEPS, OPHTHALMIC | 290DE IMP GMP | Division of Southwest Imports (DSWI) |
| 8/29/2016 | 79LRWSCISSORS, GENERAL USE, SURGICAL | 290DE IMP GMP | Division of Southwest Imports (DSWI) |
| 8/29/2016 | 79MDMINSTRUMENT, MANUAL, GENERAL SURGICAL | 290DE IMP GMP | Division of Southwest Imports (DSWI) |
| 8/29/2016 | 79GENFORCEPS, GENERAL & PLASTIC SURGERY | 290DE IMP GMP | Division of Southwest Imports (DSWI) |
| 8/29/2016 | 79GENFORCEPS, GENERAL & PLASTIC SURGERY | 290DE IMP GMP | Division of Southwest Imports (DSWI) |
| 8/29/2016 | 79LRWSCISSORS, GENERAL USE, SURGICAL | 290DE IMP GMP | Division of Southwest Imports (DSWI) |
| 8/29/2016 | 79HRQHEMOSTAT | 290DE IMP GMP | Division of Southwest Imports (DSWI) |
| 6/6/2016 | 79LRWSCISSORS, GENERAL USE, SURGICAL | 480STAINSTEEL | Division of Northeast Imports (DNEI) |
| 6/6/2016 | 77JYRNIPPER, MALLEUS | 480STAINSTEEL | Division of Northeast Imports (DNEI) |
| 6/6/2016 | 79GENFORCEPS, GENERAL & PLASTIC SURGERY | 480STAINSTEEL | Division of Northeast Imports (DNEI) |
| 6/6/2016 | 79GENFORCEPS, GENERAL & PLASTIC SURGERY | 480STAINSTEEL | Division of Northeast Imports (DNEI) |
| 7/30/2012 | 87HXKHOLDER, NEEDLE; ORTHOPEDIC | 118NOT LISTED | Southwest Import District Office (SWI-DO) |
| 7/30/2012 | 79HRQHEMOSTAT | 118NOT LISTED | Southwest Import District Office (SWI-DO) |
| 7/30/2012 | 79LRWSCISSORS, GENERAL USE, SURGICAL | 118NOT LISTED | Southwest Import District Office (SWI-DO) |
| 7/30/2012 | 79HRQHEMOSTAT | 118NOT LISTED | Southwest Import District Office (SWI-DO) |
| 7/30/2012 | 79HRQHEMOSTAT | 118NOT LISTED | Southwest Import District Office (SWI-DO) |
| 7/30/2012 | 79HRQHEMOSTAT | 118NOT LISTED | Southwest Import District Office (SWI-DO) |
| 4/11/2012 | 79FSMTRAY, SURGICAL, INSTRUMENT | 479DV QUALITY | Southwest Import District Office (SWI-DO) |
| 3/29/2012 | 79FSMTRAY, SURGICAL, INSTRUMENT | 479DV QUALITY | Southwest Import District Office (SWI-DO) |
| 2/17/2012 | 79FSMTRAY, SURGICAL, INSTRUMENT | Southwest Import District Office (SWI-DO) | |
| 1/12/2012 | 79LRPTRAY, SURGICAL | 480STAINSTEEL | Southwest Import District Office (SWI-DO) |
| 11/14/2011 | 79FSMTRAY, SURGICAL, INSTRUMENT | Southwest Import District Office (SWI-DO) | |
| 10/3/2011 | 79FSMTRAY, SURGICAL, INSTRUMENT | Southwest Import District Office (SWI-DO) | |
| 9/7/2011 | 79FSMTRAY, SURGICAL, INSTRUMENT | Southwest Import District Office (SWI-DO) | |
| 9/6/2011 | 79HRQHEMOSTAT | 118NOT LISTED | Southwest Import District Office (SWI-DO) |
| 9/6/2011 | 79HRQHEMOSTAT | 118NOT LISTED | Southwest Import District Office (SWI-DO) |
| 9/6/2011 | 79HRQHEMOSTAT | 118NOT LISTED | Southwest Import District Office (SWI-DO) |
| 9/6/2011 | 79LRWSCISSORS, GENERAL USE, SURGICAL | 118NOT LISTED | Southwest Import District Office (SWI-DO) |
| 8/26/2011 | 79HRQHEMOSTAT | 118NOT LISTED | Southwest Import District Office (SWI-DO) |
| 8/26/2011 | 79HRQHEMOSTAT | 118NOT LISTED | Southwest Import District Office (SWI-DO) |
| 8/26/2011 | 79HRQHEMOSTAT | 118NOT LISTED | Southwest Import District Office (SWI-DO) |
| 8/26/2011 | 79LRWSCISSORS, GENERAL USE, SURGICAL | 118NOT LISTED | Southwest Import District Office (SWI-DO) |
| 8/26/2011 | 79HRQHEMOSTAT | 118NOT LISTED | Southwest Import District Office (SWI-DO) |
| 8/26/2011 | 79HRQHEMOSTAT | 118NOT LISTED | Southwest Import District Office (SWI-DO) |
| 8/25/2011 | 79HRQHEMOSTAT | 118NOT LISTED | Southwest Import District Office (SWI-DO) |
| 8/25/2011 | 79LRWSCISSORS, GENERAL USE, SURGICAL | 118NOT LISTED | Southwest Import District Office (SWI-DO) |
| 8/23/2011 | 79HRQHEMOSTAT | 118NOT LISTED | Southwest Import District Office (SWI-DO) |
| 8/23/2011 | 79HRQHEMOSTAT | 118NOT LISTED | Southwest Import District Office (SWI-DO) |
| 8/23/2011 | 79LRWSCISSORS, GENERAL USE, SURGICAL | 118NOT LISTED | Southwest Import District Office (SWI-DO) |
| 8/23/2011 | 79HRQHEMOSTAT | 118NOT LISTED | Southwest Import District Office (SWI-DO) |
| 8/18/2011 | 79HRQHEMOSTAT | 118NOT LISTED | Southwest Import District Office (SWI-DO) |
| 8/18/2011 | 79LRWSCISSORS, GENERAL USE, SURGICAL | 118NOT LISTED | Southwest Import District Office (SWI-DO) |
| 8/18/2011 | 79HRQHEMOSTAT | 118NOT LISTED | Southwest Import District Office (SWI-DO) |
| 8/18/2011 | 79HRQHEMOSTAT | 118NOT LISTED | Southwest Import District Office (SWI-DO) |
| 8/18/2011 | 79LRWSCISSORS, GENERAL USE, SURGICAL | 118NOT LISTED | Southwest Import District Office (SWI-DO) |
| 8/18/2011 | 79HRQHEMOSTAT | 118NOT LISTED | Southwest Import District Office (SWI-DO) |
| 8/18/2011 | 79HRQHEMOSTAT | 118NOT LISTED | Southwest Import District Office (SWI-DO) |
| 8/18/2011 | 79HRQHEMOSTAT | 118NOT LISTED | Southwest Import District Office (SWI-DO) |
| 8/18/2011 | 79LRWSCISSORS, GENERAL USE, SURGICAL | 118NOT LISTED | Southwest Import District Office (SWI-DO) |
| 8/17/2011 | 79LRWSCISSORS, GENERAL USE, SURGICAL | 118NOT LISTED | Southwest Import District Office (SWI-DO) |
| 8/17/2011 | 87HXKHOLDER, NEEDLE; ORTHOPEDIC | 118NOT LISTED | Southwest Import District Office (SWI-DO) |
| 8/17/2011 | 79LRWSCISSORS, GENERAL USE, SURGICAL | 118NOT LISTED | Southwest Import District Office (SWI-DO) |
| 8/17/2011 | 79HRQHEMOSTAT | 118NOT LISTED | Southwest Import District Office (SWI-DO) |
| 8/17/2011 | 79LRWSCISSORS, GENERAL USE, SURGICAL | 118NOT LISTED | Southwest Import District Office (SWI-DO) |
| 8/17/2011 | 79GENFORCEPS, GENERAL & PLASTIC SURGERY | 118NOT LISTED | Southwest Import District Office (SWI-DO) |
| 8/17/2011 | 79HRQHEMOSTAT | 118NOT LISTED | Southwest Import District Office (SWI-DO) |
| 8/17/2011 | 79LRWSCISSORS, GENERAL USE, SURGICAL | 118NOT LISTED | Southwest Import District Office (SWI-DO) |
| 8/17/2011 | 79HRQHEMOSTAT | 118NOT LISTED | Southwest Import District Office (SWI-DO) |
Frequently Asked Questions
What is Tinopal Surgical Corp. (Pvt) Ltd.'s FDA import refusal history?
Tinopal Surgical Corp. (Pvt) Ltd. (FEI: 3002808350) has 1050 FDA import refusal record(s) in our database, spanning from 5/2/2007 to 3/14/2017.
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. Tinopal Surgical Corp. (Pvt) Ltd.'s FEI number is 3002808350.
What types of violations has Tinopal Surgical Corp. (Pvt) Ltd. received?
Tinopal Surgical Corp. (Pvt) Ltd. has been cited for 7 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 Tinopal Surgical Corp. (Pvt) Ltd. come from?
All FDA import refusal data for Tinopal Surgical Corp. (Pvt) 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.