Hitter Impex
⚠️ High Risk
FEI: 3005147215 • Sailkot • PAKISTAN
FEI Number
3005147215
Location
Sailkot
Country
PAKISTANAddress
Gali Pco Wali, , Sailkot, , 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.
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 9/18/2005 | 79LRWSCISSORS, GENERAL USE, SURGICAL | 480STAINSTEEL | New Orleans District Office (NOL-DO) |
| 9/18/2005 | 78FHQHOLDER, NEEDLE | 480STAINSTEEL | New Orleans District Office (NOL-DO) |
| 9/18/2005 | 78FHBHOOK, GASTRO-UROLOGY | 480STAINSTEEL | New Orleans District Office (NOL-DO) |
| 9/18/2005 | 79GDZHANDLE, SCALPEL | 480STAINSTEEL | New Orleans District Office (NOL-DO) |
| 9/18/2005 | 79GADRETRACTOR, SURGICAL, GENERAL & PLASTIC SURGERY | 480STAINSTEEL | New Orleans District Office (NOL-DO) |
| 9/18/2005 | 79GENFORCEPS, GENERAL & PLASTIC SURGERY | 480STAINSTEEL | New Orleans District Office (NOL-DO) |
| 9/18/2005 | 79GEGELEVATOR, SURGICAL, GENERAL & PLASTIC SURGERY | 480STAINSTEEL | New Orleans District Office (NOL-DO) |
| 9/18/2005 | 79GENFORCEPS, GENERAL & PLASTIC SURGERY | 480STAINSTEEL | New Orleans District Office (NOL-DO) |
| 7/21/2005 | 79JYKHOLDER, EAR SPECULUM | New Orleans District Office (NOL-DO) | |
| 7/21/2005 | 79GDGHOOK, SURGICAL, GENERAL & PLASTIC SURGERY | New Orleans District Office (NOL-DO) | |
| 7/21/2005 | 79GDZHANDLE, SCALPEL | New Orleans District Office (NOL-DO) | |
| 7/21/2005 | 79LRWSCISSORS, GENERAL USE, SURGICAL | New Orleans District Office (NOL-DO) | |
| 7/21/2005 | 79HXMRETRACTOR | New Orleans District Office (NOL-DO) | |
| 7/21/2005 | 79HTEELEVATOR | New Orleans District Office (NOL-DO) | |
| 7/21/2005 | 87HTXRONGEUR | New Orleans District Office (NOL-DO) | |
| 7/21/2005 | 79HTDFORCEPS | New Orleans District Office (NOL-DO) | |
| 7/21/2005 | 79LRZSCREWDRIVER, SURGICAL | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Hitter Impex's FDA import refusal history?
Hitter Impex (FEI: 3005147215) has 17 FDA import refusal record(s) in our database, spanning from 7/21/2005 to 9/18/2005.
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. Hitter Impex's FEI number is 3005147215.
What types of violations has Hitter Impex received?
Hitter Impex 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 Hitter Impex come from?
All FDA import refusal data for Hitter Impex 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.