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Wibi Instruments

⚠️ Moderate Risk

FEI: 3009222256 • Sialkot, Punjab • PAKISTAN

FEI

FEI Number

3009222256

📍

Location

Sialkot, Punjab

🇵🇰

Country

PAKISTAN
🏢

Address

Defence Road Chowk Fateh Garh, , 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
7/31/2013
Latest Refusal
7/31/2013
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
7/31/2013
80JOKSCISSORS, MEDICAL, DISPOSABLE
480STAINSTEEL
Division of Northeast Imports (DNEI)
7/31/2013
79HTDFORCEPS
480STAINSTEEL
Division of Northeast Imports (DNEI)

Frequently Asked Questions

What is Wibi Instruments's FDA import refusal history?

Wibi Instruments (FEI: 3009222256) has 2 FDA import refusal record(s) in our database, spanning from 7/31/2013 to 7/31/2013.

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. Wibi Instruments's FEI number is 3009222256.

What types of violations has Wibi Instruments received?

Wibi Instruments 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 Wibi Instruments come from?

All FDA import refusal data for Wibi Instruments 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.