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G-14 Surgical

⚠️ Moderate Risk

FEI: 3008035579 • Sialkot • PAKISTAN

FEI

FEI Number

3008035579

📍

Location

Sialkot

🇵🇰

Country

PAKISTAN
🏢

Address

Mustafa Town Fathe Ghar Po Box 51310, , Sialkot, , Pakistan

Moderate Risk

FDA Import Risk Assessment

45.6
LowModerateHighCritical

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

Statistics

5
Total Refusals
1
Unique Violations
2/3/2010
Latest Refusal
2/3/2010
Earliest Refusal

Score Breakdown

Violation Severity
80.0×40%
Refusal Volume
28.8×30%
Recency
0.0×20%
Frequency
50.0×10%
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

4805×

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
2/3/2010
79HTCPLIERS, SURGICAL
480STAINSTEEL
New York District Office (NYK-DO)
2/3/2010
79HRQHEMOSTAT
480STAINSTEEL
New York District Office (NYK-DO)
2/3/2010
80FQASCALE, SURGICAL SPONGE
480STAINSTEEL
New York District Office (NYK-DO)
2/3/2010
79GDJCLAMP, SURGICAL, GENERAL & PLASTIC SURGERY
480STAINSTEEL
New York District Office (NYK-DO)
2/3/2010
79LRWSCISSORS, GENERAL USE, SURGICAL
480STAINSTEEL
New York District Office (NYK-DO)

Frequently Asked Questions

What is G-14 Surgical's FDA import refusal history?

G-14 Surgical (FEI: 3008035579) has 5 FDA import refusal record(s) in our database, spanning from 2/3/2010 to 2/3/2010.

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. G-14 Surgical's FEI number is 3008035579.

What types of violations has G-14 Surgical received?

G-14 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 G-14 Surgical come from?

All FDA import refusal data for G-14 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.