Qayum and Elahisons Pvt Ltd.
⚠️ Moderate Risk
FEI: 3004525120 • Sialkot, Punjab • PAKISTAN
FEI Number
3004525120
Location
Sialkot, Punjab
Country
PAKISTANAddress
Kashmir Road, , Sialkot, Punjab, Pakistan
Moderate Risk
FDA Import Risk Assessment
This firm has a moderate history of FDA import refusals. Some attention may be warranted.
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).
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).
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 7/9/2015 | 76EBHMATERIAL, IMPRESSION TRAY, RESIN | Cincinnati District Office (CIN-DO) | |
| 7/9/2015 | 76EGNSCISSORS, SURGICAL TISSUE, DENTAL | Cincinnati District Office (CIN-DO) | |
| 7/9/2015 | 89IQGADAPTOR, HOLDER, SYRINGE | Cincinnati District Office (CIN-DO) | |
| 7/9/2015 | 87HXZCUTTER, WIRE | Cincinnati District Office (CIN-DO) | |
| 7/9/2015 | 76EIFACCESSORIES, RETRACTOR, DENTAL | Cincinnati District Office (CIN-DO) | |
| 7/9/2015 | 76EMGFORCEPS, TOOTH EXTRACTOR, SURGICAL | Cincinnati District Office (CIN-DO) | |
| 7/9/2015 | 76EGNSCISSORS, SURGICAL TISSUE, DENTAL | Cincinnati District Office (CIN-DO) | |
| 3/19/2008 | 76EMSCURETTE, PERIODONTIC | 480STAINSTEEL | New York District Office (NYK-DO) |
| 7/20/2004 | 79GADRETRACTOR, SURGICAL, GENERAL & PLASTIC SURGERY | 480STAINSTEEL | New York District Office (NYK-DO) |
| 4/22/2004 | 86HNGRONGEUR, LACHRYMAL SAC | New York District Office (NYK-DO) | |
| 12/19/2003 | 79GENFORCEPS, GENERAL & PLASTIC SURGERY | Cincinnati District Office (CIN-DO) | |
| 12/19/2003 | 79LRWSCISSORS, GENERAL USE, SURGICAL | Cincinnati District Office (CIN-DO) | |
| 12/19/2003 | 78FHQHOLDER, NEEDLE | 118NOT LISTED | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is Qayum and Elahisons Pvt Ltd.'s FDA import refusal history?
Qayum and Elahisons Pvt Ltd. (FEI: 3004525120) has 13 FDA import refusal record(s) in our database, spanning from 12/19/2003 to 7/9/2015.
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. Qayum and Elahisons Pvt Ltd.'s FEI number is 3004525120.
What types of violations has Qayum and Elahisons Pvt Ltd. received?
Qayum and Elahisons 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 Qayum and Elahisons Pvt Ltd. come from?
All FDA import refusal data for Qayum and Elahisons 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.