Garana Industries
⚠️ High Risk
FEI: 3003759558 • Sialkot, PUNJAB • PAKISTAN
FEI Number
3003759558
Location
Sialkot, PUNJAB
Country
PAKISTANAddress
Christian Town, , 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?
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
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).
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).
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).
NO 510(K)
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 5/11/2005 | 79GESBLADE, SCALPEL | New York District Office (NYK-DO) | |
| 12/13/2004 | 76NRQBLADE-FROM ENDOSSEOUS DENTAL IMPLANT | 290DE IMP GMP | New Orleans District Office (NOL-DO) |
| 12/13/2004 | 76EJBHANDLE, INSTRUMENT, DENTAL | 290DE IMP GMP | New Orleans District Office (NOL-DO) |
| 12/13/2004 | 76EAXMIRROR, MOUTH | 290DE IMP GMP | New Orleans District Office (NOL-DO) |
| 7/12/2004 | 79GDGHOOK, SURGICAL, GENERAL & PLASTIC SURGERY | 480STAINSTEEL | New York District Office (NYK-DO) |
| 7/12/2004 | 79LRWSCISSORS, GENERAL USE, SURGICAL | 480STAINSTEEL | New York District Office (NYK-DO) |
| 7/12/2004 | 87HXBPROBE | 480STAINSTEEL | New York District Office (NYK-DO) |
| 7/12/2004 | 87HXBPROBE | 480STAINSTEEL | New York District Office (NYK-DO) |
| 7/12/2004 | 79GDZHANDLE, SCALPEL | 480STAINSTEEL | New York District Office (NYK-DO) |
| 7/12/2004 | 79GENFORCEPS, GENERAL & PLASTIC SURGERY | 480STAINSTEEL | New York District Office (NYK-DO) |
| 7/12/2004 | 78FHQHOLDER, NEEDLE | 480STAINSTEEL | New York District Office (NYK-DO) |
| 7/12/2004 | 76EFLFORCEPS, DRESSING, DENTAL | 480STAINSTEEL | New York District Office (NYK-DO) |
| 7/12/2004 | 79GENFORCEPS, GENERAL & PLASTIC SURGERY | 480STAINSTEEL | New York District Office (NYK-DO) |
| 7/12/2004 | 79LRWSCISSORS, GENERAL USE, SURGICAL | 480STAINSTEEL | New York District Office (NYK-DO) |
| 7/9/2004 | 77ERAOTOSCOPE | 480STAINSTEEL | New York District Office (NYK-DO) |
| 8/20/2003 | 73BTOTUBE, TRACHEOSTOMY (W/WO CONNECTOR) | New York District Office (NYK-DO) | |
| 3/6/2003 | 79LRWSCISSORS, GENERAL USE, SURGICAL | 290DE IMP GMP | New York District Office (NYK-DO) |
| 3/6/2003 | 76EIGRETRACTOR, ALL TYPES | 290DE IMP GMP | New York District Office (NYK-DO) |
| 3/6/2003 | 79GDZHANDLE, SCALPEL | 290DE IMP GMP | New York District Office (NYK-DO) |
| 3/6/2003 | 76EFLFORCEPS, DRESSING, DENTAL | 290DE IMP GMP | New York District Office (NYK-DO) |
| 3/6/2003 | 79GENFORCEPS, GENERAL & PLASTIC SURGERY | 290DE IMP GMP | New York District Office (NYK-DO) |
| 3/5/2003 | 79LRWSCISSORS, GENERAL USE, SURGICAL | 290DE IMP GMP | New York District Office (NYK-DO) |
| 3/5/2003 | 76EFLFORCEPS, DRESSING, DENTAL | 290DE IMP GMP | New York District Office (NYK-DO) |
| 3/5/2003 | 78FHQHOLDER, NEEDLE | 290DE IMP GMP | New York District Office (NYK-DO) |
| 3/5/2003 | 79GENFORCEPS, GENERAL & PLASTIC SURGERY | 290DE IMP GMP | New York District Office (NYK-DO) |
| 3/4/2003 | 79LRWSCISSORS, GENERAL USE, SURGICAL | 290DE IMP GMP | New York District Office (NYK-DO) |
| 3/4/2003 | 87HXBPROBE | 290DE IMP GMP | New York District Office (NYK-DO) |
| 3/4/2003 | 79FZTCUTTER, SURGICAL | 290DE IMP GMP | New York District Office (NYK-DO) |
| 3/4/2003 | 86HNRFORCEPS, OPHTHALMIC | 290DE IMP GMP | New York District Office (NYK-DO) |
| 3/4/2003 | 79GDJCLAMP, SURGICAL, GENERAL & PLASTIC SURGERY | 290DE IMP GMP | New York District Office (NYK-DO) |
| 3/4/2003 | 76EFLFORCEPS, DRESSING, DENTAL | 290DE IMP GMP | New York District Office (NYK-DO) |
| 3/4/2003 | 78FHQHOLDER, NEEDLE | 290DE IMP GMP | New York District Office (NYK-DO) |
| 3/4/2003 | 79GENFORCEPS, GENERAL & PLASTIC SURGERY | 290DE IMP GMP | New York District Office (NYK-DO) |
| 1/28/2003 | 79LRWSCISSORS, GENERAL USE, SURGICAL | 290DE IMP GMP | New York District Office (NYK-DO) |
| 1/28/2003 | 77KAEFORCEPS, ENT | 290DE IMP GMP | New York District Office (NYK-DO) |
| 1/28/2003 | 79GDZHANDLE, SCALPEL | 290DE IMP GMP | New York District Office (NYK-DO) |
| 1/28/2003 | 76EFLFORCEPS, DRESSING, DENTAL | 290DE IMP GMP | New York District Office (NYK-DO) |
| 1/28/2003 | 78FHQHOLDER, NEEDLE | 290DE IMP GMP | New York District Office (NYK-DO) |
| 1/28/2003 | 79GENFORCEPS, GENERAL & PLASTIC SURGERY | 290DE IMP GMP | New York District Office (NYK-DO) |
| 8/8/2002 | 87HXBPROBE | 480STAINSTEEL | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Garana Industries's FDA import refusal history?
Garana Industries (FEI: 3003759558) has 40 FDA import refusal record(s) in our database, spanning from 8/8/2002 to 5/11/2005.
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. Garana Industries's FEI number is 3003759558.
What types of violations has Garana Industries received?
Garana Industries has been cited for 5 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 Garana Industries come from?
All FDA import refusal data for Garana Industries 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.