Javaria International

⚠️ Moderate Risk

FEI: 3003330499 • Sialkot, Punjab • PAKISTAN

FEI

FEI Number

3003330499

📍

Location

Sialkot, Punjab

🇵🇰

Country

PAKISTAN

🏢

Address

Burish Bldg., Taj Pura, Pob #2833, Khadam Ali Road, Sialkot, Punjab, Pakistan

Moderate Risk

FDA Import Risk Assessment

38.6

LowModerateHighCritical

This firm has a moderate history of FDA import refusals. Some attention may be warranted.

Statistics

Total Refusals

Unique Violations

3/31/2005

Latest Refusal

6/27/2002

Earliest Refusal

Score Breakdown

Violation Severity

67.5×40%

Refusal Volume

31.3×30%

Recency

0.0×20%

Frequency

21.7×10%

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

Violation Summary

4806×

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.

3412×

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
3/31/2005	79LRRKIT, FIRST AID	480STAINSTEEL	New York District Office (NYK-DO)
3/31/2005	79FSMTRAY, SURGICAL, INSTRUMENT	480STAINSTEEL	New York District Office (NYK-DO)
8/16/2004	79GENFORCEPS, GENERAL & PLASTIC SURGERY	480STAINSTEEL	New York District Office (NYK-DO)
6/17/2003	79GENFORCEPS, GENERAL & PLASTIC SURGERY	341REGISTERED 480STAINSTEEL	New York District Office (NYK-DO)
6/3/2003	79GENFORCEPS, GENERAL & PLASTIC SURGERY	341REGISTERED 480STAINSTEEL	New York District Office (NYK-DO)
6/27/2002	79GENFORCEPS, GENERAL & PLASTIC SURGERY	480STAINSTEEL	New York District Office (NYK-DO)

Frequently Asked Questions

What is Javaria International's FDA import refusal history?

Javaria International (FEI: 3003330499) has 6 FDA import refusal record(s) in our database, spanning from 6/27/2002 to 3/31/2005.

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 3003330499.

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.