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Frontline Surgical (Pvt) Ltd.

⚠️ Moderate Risk

FEI: 3002807033 • Paka Garha, Sialkot • PAKISTAN

FEI

FEI Number

3002807033

📍

Location

Paka Garha, Sialkot

🇵🇰

Country

PAKISTAN
🏢

Address

POB 1595, Liaqat Ali Road, St. 6, , Paka Garha, Sialkot, Pakistan

Moderate Risk

FDA Import Risk Assessment

43.8
LowModerateHighCritical

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

Statistics

4
Total Refusals
1
Unique Violations
6/16/2003
Latest Refusal
6/13/2003
Earliest Refusal

Score Breakdown

Violation Severity
80.0×40%
Refusal Volume
25.9×30%
Recency
0.0×20%
Frequency
40.0×10%
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

4804×

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
6/16/2003
80LDQDEVICE, GENERAL MEDICAL
480STAINSTEEL
Chicago District Office (CHI-DO)
6/16/2003
80LDQDEVICE, GENERAL MEDICAL
480STAINSTEEL
Chicago District Office (CHI-DO)
6/16/2003
80LDQDEVICE, GENERAL MEDICAL
480STAINSTEEL
Chicago District Office (CHI-DO)
6/13/2003
80LDQDEVICE, GENERAL MEDICAL
480STAINSTEEL
Chicago District Office (CHI-DO)

Frequently Asked Questions

What is Frontline Surgical (Pvt) Ltd.'s FDA import refusal history?

Frontline Surgical (Pvt) Ltd. (FEI: 3002807033) has 4 FDA import refusal record(s) in our database, spanning from 6/13/2003 to 6/16/2003.

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. Frontline Surgical (Pvt) Ltd.'s FEI number is 3002807033.

What types of violations has Frontline Surgical (Pvt) Ltd. received?

Frontline Surgical (Pvt) Ltd. 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 Frontline Surgical (Pvt) Ltd. come from?

All FDA import refusal data for Frontline Surgical (Pvt) Ltd. 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.