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Biggun

⚠️ Moderate Risk

FEI: 3007945331 • Sialkot, Punjab • PAKISTAN

FEI

FEI Number

3007945331

📍

Location

Sialkot, Punjab

🇵🇰

Country

PAKISTAN
🏢

Address

Gun, , Sialkot, Punjab, Pakistan

Moderate Risk

FDA Import Risk Assessment

39.3
LowModerateHighCritical

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

Statistics

2
Total Refusals
1
Unique Violations
1/26/2011
Latest Refusal
12/16/2010
Earliest Refusal

Score Breakdown

Violation Severity
80.0×40%
Refusal Volume
17.7×30%
Recency
0.0×20%
Frequency
20.0×10%
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

© ImportRefusal.com Original Analysis

Violation Summary

4802×

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.

Refusal History

DateProductViolationsDivision
1/26/2011
79LRWSCISSORS, GENERAL USE, SURGICAL
480STAINSTEEL
Chicago District Office (CHI-DO)
12/16/2010
79HTDFORCEPS
480STAINSTEEL
Chicago District Office (CHI-DO)

Frequently Asked Questions

What is Biggun's FDA import refusal history?

Biggun (FEI: 3007945331) has 2 FDA import refusal record(s) in our database, spanning from 12/16/2010 to 1/26/2011.

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. Biggun's FEI number is 3007945331.

What types of violations has Biggun received?

Biggun 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 Biggun come from?

All FDA import refusal data for Biggun 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.