Elbrus Surgical
⚠️ Moderate Risk
FEI: 3011594872 • Sialkot, Punjab • PAKISTAN
FEI Number
3011594872
Location
Sialkot, Punjab
Country
PAKISTANAddress
Khajooriwal Chowk Near Nadra Off, , 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).
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).
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 |
|---|---|---|---|
| 7/28/2015 | 79FXESPECULUM, NON-ILLUMINATED | Division of Southeast Imports (DSEI) | |
| 7/28/2015 | 79GCCDILATOR, CATHETER | Division of Southeast Imports (DSEI) | |
| 7/28/2015 | 79LRWSCISSORS, GENERAL USE, SURGICAL | Division of Southeast Imports (DSEI) | |
| 7/28/2015 | 79GENFORCEPS, GENERAL & PLASTIC SURGERY | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Elbrus Surgical's FDA import refusal history?
Elbrus Surgical (FEI: 3011594872) has 4 FDA import refusal record(s) in our database, spanning from 7/28/2015 to 7/28/2015.
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. Elbrus Surgical's FEI number is 3011594872.
What types of violations has Elbrus Surgical received?
Elbrus Surgical 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 Elbrus Surgical come from?
All FDA import refusal data for Elbrus Surgical 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.