K T Surgico (PVT) Ltd.
⚠️ High Risk
FEI: 3002807418 • Sialkot • PAKISTAN
FEI
FEI Number
3002807418
📍
Location
Sialkot
🇵🇰
Country
PAKISTAN🏢
Address
Rang Pura Rd. Pindl Arainyan, P.O. Box 1830, Sialkot, , Pakistan
High Risk
FDA Import Risk Assessment
54.6
LowModerateHighCritical
This firm has a significant history of FDA import refusals with notable violations.
Statistics
126
Total Refusals
3
Unique Violations
7/24/2012
Latest Refusal
4/14/2006
Earliest Refusal
Score Breakdown
Violation Severity
53.0×40%
Refusal Volume
77.9×30%
Recency
0.0×20%
Frequency
100.0×10%
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
34147×
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).
29044×
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).
11835×
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 7/24/2012 | 80JOKSCISSORS, MEDICAL, DISPOSABLE | 290DE IMP GMP | Southwest Import District Office (SWI-DO) |
| 7/24/2012 | 80JOKSCISSORS, MEDICAL, DISPOSABLE | 290DE IMP GMP | Southwest Import District Office (SWI-DO) |
| 7/24/2012 | 80JOKSCISSORS, MEDICAL, DISPOSABLE | 290DE IMP GMP | Southwest Import District Office (SWI-DO) |
| 6/26/2012 | 79GENFORCEPS, GENERAL & PLASTIC SURGERY | 290DE IMP GMP | Southwest Import District Office (SWI-DO) |
| 5/18/2012 | 79GENFORCEPS, GENERAL & PLASTIC SURGERY | 290DE IMP GMP | Southwest Import District Office (SWI-DO) |
| 4/20/2012 | 78FHQHOLDER, NEEDLE | 290DE IMP GMP | Atlanta District Office (ATL-DO) |
| 4/20/2012 | 79GDGHOOK, SURGICAL, GENERAL & PLASTIC SURGERY | 290DE IMP GMP | Atlanta District Office (ATL-DO) |
| 4/20/2012 | 78FHQHOLDER, NEEDLE | 290DE IMP GMP | Atlanta District Office (ATL-DO) |
| 4/20/2012 | 79FZYHAMMER, SURGICAL | 290DE IMP GMP | Atlanta District Office (ATL-DO) |
| 4/20/2012 | 79HXMRETRACTOR | 290DE IMP GMP | Atlanta District Office (ATL-DO) |
| 4/20/2012 | 80JOKSCISSORS, MEDICAL, DISPOSABLE | 290DE IMP GMP | Atlanta District Office (ATL-DO) |
| 4/20/2012 | 79HXMRETRACTOR | 290DE IMP GMP | Atlanta District Office (ATL-DO) |
| 4/20/2012 | 85HCZFORCEPS, SURGICAL, GYNECOLOGICAL | 290DE IMP GMP | Atlanta District Office (ATL-DO) |
| 4/20/2012 | 79HXMRETRACTOR | 290DE IMP GMP | Atlanta District Office (ATL-DO) |
| 4/20/2012 | 85HCZFORCEPS, SURGICAL, GYNECOLOGICAL | 290DE IMP GMP | Atlanta District Office (ATL-DO) |
| 4/20/2012 | 85HCZFORCEPS, SURGICAL, GYNECOLOGICAL | 290DE IMP GMP | Atlanta District Office (ATL-DO) |
| 4/20/2012 | 79GDJCLAMP, SURGICAL, GENERAL & PLASTIC SURGERY | 290DE IMP GMP | Atlanta District Office (ATL-DO) |
| 4/20/2012 | 80JOKSCISSORS, MEDICAL, DISPOSABLE | 290DE IMP GMP | Atlanta District Office (ATL-DO) |
| 4/20/2012 | 80JOKSCISSORS, MEDICAL, DISPOSABLE | 290DE IMP GMP | Atlanta District Office (ATL-DO) |
| 4/20/2012 | 80JOKSCISSORS, MEDICAL, DISPOSABLE | 290DE IMP GMP | Atlanta District Office (ATL-DO) |
| 4/20/2012 | 80JOKSCISSORS, MEDICAL, DISPOSABLE | 290DE IMP GMP | Atlanta District Office (ATL-DO) |
| 4/20/2012 | 79FXESPECULUM, NON-ILLUMINATED | 290DE IMP GMP | Atlanta District Office (ATL-DO) |
| 4/20/2012 | 79GDJCLAMP, SURGICAL, GENERAL & PLASTIC SURGERY | 290DE IMP GMP | Atlanta District Office (ATL-DO) |
| 4/20/2012 | 79GENFORCEPS, GENERAL & PLASTIC SURGERY | 290DE IMP GMP | Atlanta District Office (ATL-DO) |
| 4/20/2012 | 80JOKSCISSORS, MEDICAL, DISPOSABLE | 290DE IMP GMP | Atlanta District Office (ATL-DO) |
| 4/20/2012 | 79GDJCLAMP, SURGICAL, GENERAL & PLASTIC SURGERY | 290DE IMP GMP | Atlanta District Office (ATL-DO) |
| 4/20/2012 | 78FHQHOLDER, NEEDLE | 290DE IMP GMP | Atlanta District Office (ATL-DO) |
| 4/20/2012 | 79HXMRETRACTOR | 290DE IMP GMP | Atlanta District Office (ATL-DO) |
| 4/20/2012 | 79HXMRETRACTOR | 290DE IMP GMP | Atlanta District Office (ATL-DO) |
| 4/20/2012 | 79HXMRETRACTOR | 290DE IMP GMP | Atlanta District Office (ATL-DO) |
| 4/20/2012 | 79GENFORCEPS, GENERAL & PLASTIC SURGERY | 290DE IMP GMP | Atlanta District Office (ATL-DO) |
| 4/20/2012 | 79GENFORCEPS, GENERAL & PLASTIC SURGERY | 290DE IMP GMP | Atlanta District Office (ATL-DO) |
| 4/20/2012 | 79GDGHOOK, SURGICAL, GENERAL & PLASTIC SURGERY | 290DE IMP GMP | Atlanta District Office (ATL-DO) |
| 4/20/2012 | 79GDGHOOK, SURGICAL, GENERAL & PLASTIC SURGERY | 290DE IMP GMP | Atlanta District Office (ATL-DO) |
| 4/20/2012 | 79GENFORCEPS, GENERAL & PLASTIC SURGERY | 290DE IMP GMP | Atlanta District Office (ATL-DO) |
| 4/20/2012 | 80JOKSCISSORS, MEDICAL, DISPOSABLE | 290DE IMP GMP | Atlanta District Office (ATL-DO) |
| 4/20/2012 | 79HTFCURETTE | 290DE IMP GMP | Atlanta District Office (ATL-DO) |
| 4/20/2012 | 80JOKSCISSORS, MEDICAL, DISPOSABLE | 290DE IMP GMP | Atlanta District Office (ATL-DO) |
| 4/20/2012 | 79GDZHANDLE, SCALPEL | 290DE IMP GMP | Atlanta District Office (ATL-DO) |
| 4/20/2012 | 79HTFCURETTE | 290DE IMP GMP | Atlanta District Office (ATL-DO) |
| 4/20/2012 | 80JOKSCISSORS, MEDICAL, DISPOSABLE | 290DE IMP GMP | Atlanta District Office (ATL-DO) |
| 4/20/2012 | 80JOKSCISSORS, MEDICAL, DISPOSABLE | 290DE IMP GMP | Atlanta District Office (ATL-DO) |
| 4/20/2012 | 78FHQHOLDER, NEEDLE | 290DE IMP GMP | Atlanta District Office (ATL-DO) |
| 4/19/2012 | 80JOKSCISSORS, MEDICAL, DISPOSABLE | 118NOT LISTED | Atlanta District Office (ATL-DO) |
| 4/19/2012 | 80JOKSCISSORS, MEDICAL, DISPOSABLE | 118NOT LISTED | Atlanta District Office (ATL-DO) |
| 4/19/2012 | 79GENFORCEPS, GENERAL & PLASTIC SURGERY | 118NOT LISTED | Atlanta District Office (ATL-DO) |
| 4/19/2012 | 79GDZHANDLE, SCALPEL | 118NOT LISTED | Atlanta District Office (ATL-DO) |
| 4/19/2012 | 79HXMRETRACTOR | 118NOT LISTED | Atlanta District Office (ATL-DO) |
| 4/19/2012 | 80JOKSCISSORS, MEDICAL, DISPOSABLE | 118NOT LISTED | Atlanta District Office (ATL-DO) |
| 4/19/2012 | 84GWYPINWHEEL | 118NOT LISTED | Atlanta District Office (ATL-DO) |
| 4/19/2012 | 79HTFCURETTE | 118NOT LISTED | Atlanta District Office (ATL-DO) |
| 4/19/2012 | 79HXMRETRACTOR | 118NOT LISTED | Atlanta District Office (ATL-DO) |
| 4/19/2012 | 80JOKSCISSORS, MEDICAL, DISPOSABLE | 118NOT LISTED | Atlanta District Office (ATL-DO) |
| 4/19/2012 | 79GDJCLAMP, SURGICAL, GENERAL & PLASTIC SURGERY | 118NOT LISTED | Atlanta District Office (ATL-DO) |
| 4/19/2012 | 79FXESPECULUM, NON-ILLUMINATED | 118NOT LISTED | Atlanta District Office (ATL-DO) |
| 4/19/2012 | 85HCZFORCEPS, SURGICAL, GYNECOLOGICAL | 118NOT LISTED | Atlanta District Office (ATL-DO) |
| 4/19/2012 | 78FHQHOLDER, NEEDLE | 118NOT LISTED | Atlanta District Office (ATL-DO) |
| 4/19/2012 | 80JOKSCISSORS, MEDICAL, DISPOSABLE | 118NOT LISTED | Atlanta District Office (ATL-DO) |
| 4/19/2012 | 79GENFORCEPS, GENERAL & PLASTIC SURGERY | 118NOT LISTED | Atlanta District Office (ATL-DO) |
| 4/19/2012 | 79GENFORCEPS, GENERAL & PLASTIC SURGERY | 118NOT LISTED | Atlanta District Office (ATL-DO) |
| 4/19/2012 | 79GENFORCEPS, GENERAL & PLASTIC SURGERY | 118NOT LISTED | Atlanta District Office (ATL-DO) |
| 4/19/2012 | 79GENFORCEPS, GENERAL & PLASTIC SURGERY | 118NOT LISTED | Atlanta District Office (ATL-DO) |
| 4/19/2012 | 79GDJCLAMP, SURGICAL, GENERAL & PLASTIC SURGERY | 118NOT LISTED | Atlanta District Office (ATL-DO) |
| 4/19/2012 | 79GDJCLAMP, SURGICAL, GENERAL & PLASTIC SURGERY | 118NOT LISTED | Atlanta District Office (ATL-DO) |
| 4/19/2012 | 79GENFORCEPS, GENERAL & PLASTIC SURGERY | 118NOT LISTED | Atlanta District Office (ATL-DO) |
| 4/19/2012 | 79GENFORCEPS, GENERAL & PLASTIC SURGERY | 118NOT LISTED | Atlanta District Office (ATL-DO) |
| 4/19/2012 | 79GDZHANDLE, SCALPEL | 118NOT LISTED | Atlanta District Office (ATL-DO) |
| 4/19/2012 | 80JOKSCISSORS, MEDICAL, DISPOSABLE | 118NOT LISTED | Atlanta District Office (ATL-DO) |
| 4/19/2012 | 80JOKSCISSORS, MEDICAL, DISPOSABLE | 118NOT LISTED | Atlanta District Office (ATL-DO) |
| 4/19/2012 | 80JOKSCISSORS, MEDICAL, DISPOSABLE | 118NOT LISTED | Atlanta District Office (ATL-DO) |
| 4/19/2012 | 80JOKSCISSORS, MEDICAL, DISPOSABLE | 118NOT LISTED | Atlanta District Office (ATL-DO) |
| 4/19/2012 | 80JOKSCISSORS, MEDICAL, DISPOSABLE | 118NOT LISTED | Atlanta District Office (ATL-DO) |
| 4/19/2012 | 80JOKSCISSORS, MEDICAL, DISPOSABLE | 118NOT LISTED | Atlanta District Office (ATL-DO) |
| 4/19/2012 | 80JOKSCISSORS, MEDICAL, DISPOSABLE | 118NOT LISTED | Atlanta District Office (ATL-DO) |
| 4/19/2012 | 80JOKSCISSORS, MEDICAL, DISPOSABLE | 118NOT LISTED | Atlanta District Office (ATL-DO) |
| 3/5/2012 | 85HCZFORCEPS, SURGICAL, GYNECOLOGICAL | 341REGISTERED | Atlanta District Office (ATL-DO) |
| 3/5/2012 | 79HTFCURETTE | 341REGISTERED | Atlanta District Office (ATL-DO) |
| 3/5/2012 | 79HXMRETRACTOR | 341REGISTERED | Atlanta District Office (ATL-DO) |
| 3/5/2012 | 85HCZFORCEPS, SURGICAL, GYNECOLOGICAL | 341REGISTERED | Atlanta District Office (ATL-DO) |
| 3/5/2012 | 85HCZFORCEPS, SURGICAL, GYNECOLOGICAL | 341REGISTERED | Atlanta District Office (ATL-DO) |
| 3/5/2012 | 80JOKSCISSORS, MEDICAL, DISPOSABLE | 341REGISTERED | Atlanta District Office (ATL-DO) |
| 3/5/2012 | 80JOKSCISSORS, MEDICAL, DISPOSABLE | 341REGISTERED | Atlanta District Office (ATL-DO) |
| 3/5/2012 | 80JOKSCISSORS, MEDICAL, DISPOSABLE | 341REGISTERED | Atlanta District Office (ATL-DO) |
| 3/5/2012 | 79GDJCLAMP, SURGICAL, GENERAL & PLASTIC SURGERY | 341REGISTERED | Atlanta District Office (ATL-DO) |
| 3/5/2012 | 79GDJCLAMP, SURGICAL, GENERAL & PLASTIC SURGERY | 341REGISTERED | Atlanta District Office (ATL-DO) |
| 3/5/2012 | 79GDJCLAMP, SURGICAL, GENERAL & PLASTIC SURGERY | 341REGISTERED | Atlanta District Office (ATL-DO) |
| 3/5/2012 | 79FZYHAMMER, SURGICAL | 341REGISTERED | Atlanta District Office (ATL-DO) |
| 3/5/2012 | 80JOKSCISSORS, MEDICAL, DISPOSABLE | 341REGISTERED | Atlanta District Office (ATL-DO) |
| 3/5/2012 | 80JOKSCISSORS, MEDICAL, DISPOSABLE | 341REGISTERED | Atlanta District Office (ATL-DO) |
| 3/5/2012 | 80JOKSCISSORS, MEDICAL, DISPOSABLE | 341REGISTERED | Atlanta District Office (ATL-DO) |
| 3/5/2012 | 78FHQHOLDER, NEEDLE | 341REGISTERED | Atlanta District Office (ATL-DO) |
| 3/5/2012 | 79HXMRETRACTOR | 341REGISTERED | Atlanta District Office (ATL-DO) |
| 3/5/2012 | 79GDGHOOK, SURGICAL, GENERAL & PLASTIC SURGERY | 341REGISTERED | Atlanta District Office (ATL-DO) |
| 3/5/2012 | 79GENFORCEPS, GENERAL & PLASTIC SURGERY | 341REGISTERED | Atlanta District Office (ATL-DO) |
| 3/5/2012 | 80JOKSCISSORS, MEDICAL, DISPOSABLE | 341REGISTERED | Atlanta District Office (ATL-DO) |
| 3/5/2012 | 85HCZFORCEPS, SURGICAL, GYNECOLOGICAL | 341REGISTERED | Atlanta District Office (ATL-DO) |
| 3/5/2012 | 79HXMRETRACTOR | 341REGISTERED | Atlanta District Office (ATL-DO) |
| 3/5/2012 | 79HXMRETRACTOR | 341REGISTERED | Atlanta District Office (ATL-DO) |
| 3/5/2012 | 79HXMRETRACTOR | 341REGISTERED | Atlanta District Office (ATL-DO) |
| 3/5/2012 | 80JOKSCISSORS, MEDICAL, DISPOSABLE | 341REGISTERED | Atlanta District Office (ATL-DO) |
Frequently Asked Questions
What is K T Surgico (PVT) Ltd.'s FDA import refusal history?
K T Surgico (PVT) Ltd. (FEI: 3002807418) has 126 FDA import refusal record(s) in our database, spanning from 4/14/2006 to 7/24/2012.
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. K T Surgico (PVT) Ltd.'s FEI number is 3002807418.
What types of violations has K T Surgico (PVT) Ltd. received?
K T Surgico (PVT) Ltd. 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 K T Surgico (PVT) Ltd. come from?
All FDA import refusal data for K T Surgico (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.