ALVI Expo
⚠️ Moderate Risk
FEI: 3007751820 • Sialkot, Punjab • PAKISTAN
FEI Number
3007751820
Location
Sialkot, Punjab
Country
PAKISTANAddress
Malik Muhammad Zafar Awan House Nai Abad,Murad Pur Marala 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
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).
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 9/22/2011 | 76EJGFORCEPS, RUBBER DAM CLAMP | 290DE IMP GMP | Detroit District Office (DET-DO) |
| 8/30/2011 | 76EJGFORCEPS, RUBBER DAM CLAMP | 290DE IMP GMP | New Orleans District Office (NOL-DO) |
| 8/16/2011 | 79LRYPUNCH, SURGICAL | 290DE IMP GMP | Detroit District Office (DET-DO) |
| 4/6/2011 | 76DZNMATRIX, DENTAL | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is ALVI Expo's FDA import refusal history?
ALVI Expo (FEI: 3007751820) has 4 FDA import refusal record(s) in our database, spanning from 4/6/2011 to 9/22/2011.
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. ALVI Expo's FEI number is 3007751820.
What types of violations has ALVI Expo received?
ALVI Expo has been cited for 2 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 ALVI Expo come from?
All FDA import refusal data for ALVI Expo 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.