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Bromed Surgical

⚠️ Moderate Risk

FEI: 3006537787 • Sialket • PAKISTAN

FEI

FEI Number

3006537787

📍

Location

Sialket

🇵🇰

Country

PAKISTAN
🏢

Address

Gondal Road, , Sialket, , Pakistan

Moderate Risk

FDA Import Risk Assessment

36.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
12/19/2007
Latest Refusal
12/19/2007
Earliest Refusal

Score Breakdown

Violation Severity
80.0×40%
Refusal Volume
11.2×30%
Recency
0.0×20%
Frequency
10.0×10%
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

4801×

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
12/19/2007
79LRWSCISSORS, GENERAL USE, SURGICAL
480STAINSTEEL
New York District Office (NYK-DO)

Frequently Asked Questions

What is Bromed Surgical's FDA import refusal history?

Bromed Surgical (FEI: 3006537787) has 1 FDA import refusal record(s) in our database, spanning from 12/19/2007 to 12/19/2007.

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. Bromed Surgical's FEI number is 3006537787.

What types of violations has Bromed Surgical received?

Bromed Surgical 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 Bromed Surgical come from?

All FDA import refusal data for Bromed Surgical 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.