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Conmed International

⚠️ Moderate Risk

FEI: 3008537105 • Sialkot • PAKISTAN

FEI

FEI Number

3008537105

📍

Location

Sialkot

🇵🇰

Country

PAKISTAN
🏢

Address

Mihammad Pura, , Sialkot, , Pakistan

Moderate Risk

FDA Import Risk Assessment

46.6
LowModerateHighCritical

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

Statistics

8
Total Refusals
1
Unique Violations
11/3/2010
Latest Refusal
11/3/2010
Earliest Refusal

Score Breakdown

Violation Severity
70.0×40%
Refusal Volume
35.3×30%
Recency
0.0×20%
Frequency
80.0×10%
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

4778×

HOLES

The quality of the article falls below that which it purports or is represented to possess, in that the devices contain defects/holes.

Refusal History

DateProductViolationsDivision
11/3/2010
76EJBHANDLE, INSTRUMENT, DENTAL
477HOLES
New York District Office (NYK-DO)
11/3/2010
87HTJGAUGE, DEPTH
477HOLES
New York District Office (NYK-DO)
11/3/2010
87HXOPUSHER, SOCKET
477HOLES
New York District Office (NYK-DO)
11/3/2010
87HXEFORK
477HOLES
New York District Office (NYK-DO)
11/3/2010
80NKKNEEDLE, HYPODERMIC, SINGLE LUMEN, REPROCESSED
477HOLES
New York District Office (NYK-DO)
11/3/2010
79GADRETRACTOR, SURGICAL, GENERAL & PLASTIC SURGERY
477HOLES
New York District Office (NYK-DO)
11/3/2010
79HTDFORCEPS
477HOLES
New York District Office (NYK-DO)
11/3/2010
87HXBPROBE
477HOLES
New York District Office (NYK-DO)

Frequently Asked Questions

What is Conmed International's FDA import refusal history?

Conmed International (FEI: 3008537105) has 8 FDA import refusal record(s) in our database, spanning from 11/3/2010 to 11/3/2010.

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. Conmed International's FEI number is 3008537105.

What types of violations has Conmed International received?

Conmed International 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 Conmed International come from?

All FDA import refusal data for Conmed International 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.