ALIRA MEDICAL DEVICES (PVT) LTD
⚠️ Moderate Risk
FEI: 3025733014 • Lahore • PAKISTAN
FEI Number
3025733014
Location
Lahore
Country
PAKISTANAddress
1st Floor 223, Y Block Dha Phase 3, Lahore, , 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
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 |
|---|---|---|---|
| 2/7/2023 | 79PXVGENERAL PURPOSE INSTRUMENT TRAY | 290DE IMP GMP | Division of Southeast Imports (DSEI) |
| 2/7/2023 | 79GENFORCEPS, GENERAL & PLASTIC SURGERY | 290DE IMP GMP | Division of Southeast Imports (DSEI) |
| 2/7/2023 | 79LRWSCISSORS, GENERAL USE, SURGICAL | 290DE IMP GMP | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is ALIRA MEDICAL DEVICES (PVT) LTD's FDA import refusal history?
ALIRA MEDICAL DEVICES (PVT) LTD (FEI: 3025733014) has 3 FDA import refusal record(s) in our database, spanning from 2/7/2023 to 2/7/2023.
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. ALIRA MEDICAL DEVICES (PVT) LTD's FEI number is 3025733014.
What types of violations has ALIRA MEDICAL DEVICES (PVT) LTD received?
ALIRA MEDICAL DEVICES (PVT) LTD has been cited for 1 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 ALIRA MEDICAL DEVICES (PVT) LTD come from?
All FDA import refusal data for ALIRA MEDICAL DEVICES (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.