JAVARIA INTERNATIONAL
⚠️ Moderate Risk
FEI: 3012768084 • Lahore, Punjab • PAKISTAN
FEI Number
3012768084
Location
Lahore, Punjab
Country
PAKISTANAddress
559-Umer Block a .I . T, , Lahore, 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).
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 11/3/2016 | 76DZPINSTRUMENT, DIAMOND, DENTAL | 341REGISTERED | Division of Northern Border Imports (DNBI) |
| 11/3/2016 | 79GDIDISSECTOR, SURGICAL, GENERAL & PLASTIC SURGERY | 341REGISTERED | Division of Northern Border Imports (DNBI) |
| 11/3/2016 | 87HWCSCREW, FIXATION, BONE | 341REGISTERED | Division of Northern Border Imports (DNBI) |
| 11/3/2016 | 76EMGFORCEPS, TOOTH EXTRACTOR, SURGICAL | 341REGISTERED | Division of Northern Border Imports (DNBI) |
| 11/3/2016 | 76DZPINSTRUMENT, DIAMOND, DENTAL | 290DE IMP GMP | Division of Northern Border Imports (DNBI) |
| 11/3/2016 | 79GDIDISSECTOR, SURGICAL, GENERAL & PLASTIC SURGERY | 290DE IMP GMP | Division of Northern Border Imports (DNBI) |
| 11/3/2016 | 87HWCSCREW, FIXATION, BONE | 290DE IMP GMP | Division of Northern Border Imports (DNBI) |
| 11/3/2016 | 76EMGFORCEPS, TOOTH EXTRACTOR, SURGICAL | 290DE IMP GMP | Division of Northern Border Imports (DNBI) |
Frequently Asked Questions
What is JAVARIA INTERNATIONAL's FDA import refusal history?
JAVARIA INTERNATIONAL (FEI: 3012768084) has 8 FDA import refusal record(s) in our database, spanning from 11/3/2016 to 11/3/2016.
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. JAVARIA INTERNATIONAL's FEI number is 3012768084.
What types of violations has JAVARIA INTERNATIONAL received?
JAVARIA INTERNATIONAL 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 JAVARIA INTERNATIONAL come from?
All FDA import refusal data for JAVARIA INTERNATIONAL 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.