M/s Hi Tech International
⚠️ High Risk
FEI: 3006680969 • Sialkot • PAKISTAN
FEI Number
3006680969
Location
Sialkot
Country
PAKISTANAddress
Defense Road, Muzaffer Pur, , 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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 3/5/2010 | 79FSMTRAY, SURGICAL, INSTRUMENT | 480STAINSTEEL | New York District Office (NYK-DO) |
| 3/5/2010 | 76EEFCLAMP, RUBBER DAM | 480STAINSTEEL | New York District Office (NYK-DO) |
| 3/5/2010 | 76EHYTRAY, IMPRESSION, PREFORMED | 480STAINSTEEL | New York District Office (NYK-DO) |
| 3/5/2010 | 76JEPRETAINER, MATRIX | 480STAINSTEEL | New York District Office (NYK-DO) |
| 3/5/2010 | 76EAXMIRROR, MOUTH | 480STAINSTEEL | New York District Office (NYK-DO) |
| 3/5/2010 | 76EKHCARVER, DENTAL AMALGAM, OPERATIVE | 480STAINSTEEL | New York District Office (NYK-DO) |
| 3/5/2010 | 76EKHCARVER, DENTAL AMALGAM, OPERATIVE | 480STAINSTEEL | New York District Office (NYK-DO) |
| 3/5/2010 | 79LRWSCISSORS, GENERAL USE, SURGICAL | 480STAINSTEEL | New York District Office (NYK-DO) |
| 3/5/2010 | 76EEFCLAMP, RUBBER DAM | 480STAINSTEEL | New York District Office (NYK-DO) |
| 3/5/2010 | 76DYNMOUTHPIECE, SALIVA EJECTOR | 480STAINSTEEL | New York District Office (NYK-DO) |
| 3/5/2010 | 79HTDFORCEPS | 480STAINSTEEL | New York District Office (NYK-DO) |
| 3/5/2010 | 76EIKCARVER, WAX, DENTAL | 480STAINSTEEL | New York District Office (NYK-DO) |
| 3/5/2010 | 76EIYINSTRUMENT, FILLING, PLASTIC, DENTAL | 480STAINSTEEL | New York District Office (NYK-DO) |
| 3/5/2010 | 79GAFSPATULA, SURGICAL, GENERAL & PLASTIC SURGERY | 480STAINSTEEL | New York District Office (NYK-DO) |
| 3/5/2010 | 87HXBPROBE | 480STAINSTEEL | New York District Office (NYK-DO) |
| 3/5/2010 | 76EKCEXCAVATOR, DENTAL, OPERATIVE | 480STAINSTEEL | New York District Office (NYK-DO) |
| 3/5/2010 | 79LRWSCISSORS, GENERAL USE, SURGICAL | 480STAINSTEEL | New York District Office (NYK-DO) |
| 3/5/2010 | 78FHQHOLDER, NEEDLE | 480STAINSTEEL | New York District Office (NYK-DO) |
| 3/5/2010 | 76EMLCHISEL, BONE, SURGICAL | 480STAINSTEEL | New York District Office (NYK-DO) |
| 3/5/2010 | 76EMJELEVATOR, SURGICAL, DENTAL | 480STAINSTEEL | New York District Office (NYK-DO) |
| 3/5/2010 | 79HTDFORCEPS | 480STAINSTEEL | New York District Office (NYK-DO) |
Frequently Asked Questions
What is M/s Hi Tech International's FDA import refusal history?
M/s Hi Tech International (FEI: 3006680969) has 21 FDA import refusal record(s) in our database, spanning from 3/5/2010 to 3/5/2010.
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. M/s Hi Tech International's FEI number is 3006680969.
What types of violations has M/s Hi Tech International received?
M/s Hi Tech International has been cited for 1 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 M/s Hi Tech International come from?
All FDA import refusal data for M/s Hi Tech International 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.