Fairmont Industries Pvt Ltd.
⚠️ High Risk
FEI: 3005621481 • Sialkot, Punjab • PAKISTAN
FEI Number
3005621481
Location
Sialkot, Punjab
Country
PAKISTANAddress
Kotli Behram, , 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
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).
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
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.
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 |
|---|---|---|---|
| 6/5/2024 | 76EMJELEVATOR, SURGICAL, DENTAL | Division of Southeast Imports (DSEI) | |
| 6/5/2024 | 79GENFORCEPS, GENERAL & PLASTIC SURGERY | Division of Southeast Imports (DSEI) | |
| 6/5/2024 | 78FHQHOLDER, NEEDLE | Division of Southeast Imports (DSEI) | |
| 6/5/2024 | 79GENFORCEPS, GENERAL & PLASTIC SURGERY | Division of Southeast Imports (DSEI) | |
| 6/5/2024 | 79LRWSCISSORS, GENERAL USE, SURGICAL | Division of Southeast Imports (DSEI) | |
| 6/5/2024 | 79HTDFORCEPS | Division of Southeast Imports (DSEI) | |
| 6/5/2024 | 79LRWSCISSORS, GENERAL USE, SURGICAL | Division of Southeast Imports (DSEI) | |
| 6/5/2024 | 79GENFORCEPS, GENERAL & PLASTIC SURGERY | Division of Southeast Imports (DSEI) | |
| 6/5/2024 | 76EMGFORCEPS, TOOTH EXTRACTOR, SURGICAL | Division of Southeast Imports (DSEI) | |
| 6/5/2024 | 79LRWSCISSORS, GENERAL USE, SURGICAL | Division of Southeast Imports (DSEI) | |
| 6/5/2024 | 76EAXMIRROR, MOUTH | Division of Southeast Imports (DSEI) | |
| 6/5/2024 | 79GDZHANDLE, SCALPEL | Division of Southeast Imports (DSEI) | |
| 6/5/2024 | 76EMJELEVATOR, SURGICAL, DENTAL | Division of Southeast Imports (DSEI) | |
| 6/5/2024 | 76EMNSCALER, PERIODONTIC | Division of Southeast Imports (DSEI) | |
| 2/5/2009 | 78FHQHOLDER, NEEDLE | 290DE IMP GMP | Florida District Office (FLA-DO) |
| 2/5/2009 | 76EIYINSTRUMENT, FILLING, PLASTIC, DENTAL | 290DE IMP GMP | Florida District Office (FLA-DO) |
| 2/5/2009 | 76EIYINSTRUMENT, FILLING, PLASTIC, DENTAL | 290DE IMP GMP | Florida District Office (FLA-DO) |
| 2/14/2006 | 85HCZFORCEPS, SURGICAL, GYNECOLOGICAL | 480STAINSTEEL | New York District Office (NYK-DO) |
| 6/16/2004 | 76EIYINSTRUMENT, FILLING, PLASTIC, DENTAL | 480STAINSTEEL | New York District Office (NYK-DO) |
| 6/16/2004 | 76EKICARRIER, AMALGAM, OPERATIVE | 480STAINSTEEL | New York District Office (NYK-DO) |
| 6/16/2004 | 76EMNSCALER, PERIODONTIC | 480STAINSTEEL | New York District Office (NYK-DO) |
| 6/3/2004 | 76EMJELEVATOR, SURGICAL, DENTAL | 480STAINSTEEL | New York District Office (NYK-DO) |
| 6/3/2004 | 76EMGFORCEPS, TOOTH EXTRACTOR, SURGICAL | 480STAINSTEEL | New York District Office (NYK-DO) |
| 6/3/2004 | 76EISREMOVER, CROWN | 480STAINSTEEL | New York District Office (NYK-DO) |
| 6/3/2004 | 76EMHFORCEPS, RONGEUR, SURGICAL | 480STAINSTEEL | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Fairmont Industries Pvt Ltd.'s FDA import refusal history?
Fairmont Industries Pvt Ltd. (FEI: 3005621481) has 25 FDA import refusal record(s) in our database, spanning from 6/3/2004 to 6/5/2024.
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. Fairmont Industries Pvt Ltd.'s FEI number is 3005621481.
What types of violations has Fairmont Industries Pvt Ltd. received?
Fairmont Industries Pvt Ltd. has been cited for 4 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 Fairmont Industries Pvt Ltd. come from?
All FDA import refusal data for Fairmont Industries 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.