Technimen Skillers
⚠️ High Risk
FEI: 3003238438 • Sialkot • PAKISTAN
FEI Number
3003238438
Location
Sialkot
Country
PAKISTANAddress
P.O. Box No. 1164, , 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
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.
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 5/3/2011 | 79JYKHOLDER, EAR SPECULUM | 290DE IMP GMP | New York District Office (NYK-DO) |
| 5/29/2009 | 78FHQHOLDER, NEEDLE | 480STAINSTEEL | New York District Office (NYK-DO) |
| 5/29/2009 | 78FFQSPECULUM, RECTAL | 480STAINSTEEL | New York District Office (NYK-DO) |
| 5/29/2009 | 76DYJRETAINER, SCREW EXPANSION, ORTHODONTIC | 480STAINSTEEL | New York District Office (NYK-DO) |
| 5/29/2009 | 76EKHCARVER, DENTAL AMALGAM, OPERATIVE | 480STAINSTEEL | New York District Office (NYK-DO) |
| 5/29/2009 | 77KCPSYRINGE, ENT | 480STAINSTEEL | New York District Office (NYK-DO) |
| 5/29/2009 | 87KTZCALIPER | 480STAINSTEEL | New York District Office (NYK-DO) |
| 5/29/2009 | 79LRWSCISSORS, GENERAL USE, SURGICAL | 480STAINSTEEL | New York District Office (NYK-DO) |
| 5/29/2009 | 78FFQSPECULUM, RECTAL | 480STAINSTEEL | New York District Office (NYK-DO) |
| 5/29/2009 | 76EMIFILE, BONE, SURGICAL | 480STAINSTEEL | New York District Office (NYK-DO) |
| 5/29/2009 | 76EMJELEVATOR, SURGICAL, DENTAL | 480STAINSTEEL | New York District Office (NYK-DO) |
| 5/29/2009 | 79GDGHOOK, SURGICAL, GENERAL & PLASTIC SURGERY | 480STAINSTEEL | New York District Office (NYK-DO) |
| 5/29/2009 | 79HXMRETRACTOR | 480STAINSTEEL | New York District Office (NYK-DO) |
| 5/29/2009 | 79HXMRETRACTOR | 480STAINSTEEL | New York District Office (NYK-DO) |
| 3/16/2009 | 85HCYCURETTE, UTERINE | 2780DEVICEGMPS | New York District Office (NYK-DO) |
| 3/16/2009 | 78FFQSPECULUM, RECTAL | 2780DEVICEGMPS | New York District Office (NYK-DO) |
| 3/16/2009 | 79LRWSCISSORS, GENERAL USE, SURGICAL | 2780DEVICEGMPS | New York District Office (NYK-DO) |
| 3/16/2009 | 78FHQHOLDER, NEEDLE | 2780DEVICEGMPS | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Technimen Skillers's FDA import refusal history?
Technimen Skillers (FEI: 3003238438) has 18 FDA import refusal record(s) in our database, spanning from 3/16/2009 to 5/3/2011.
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. Technimen Skillers's FEI number is 3003238438.
What types of violations has Technimen Skillers received?
Technimen Skillers 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 Technimen Skillers come from?
All FDA import refusal data for Technimen Skillers 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.