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Marcon Rubber Industry

⚠️ Moderate Risk

FEI: 3183 • Alor Gajah, Malacca • MALAYSIA

FEI

FEI Number

3183

📍

Location

Alor Gajah, Malacca

🇲🇾

Country

MALAYSIA
🏢

Address

LOTS 27, 28 & 29, ALOR GAJAH INDUSTRIAL ESTATE, PERINGKAT-III, Alor Gajah, Malacca, Malaysia

Moderate Risk

FDA Import Risk Assessment

39.7
LowModerateHighCritical

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

Statistics

8
Total Refusals
1
Unique Violations
3/25/2010
Latest Refusal
3/6/2003
Earliest Refusal

Score Breakdown

Violation Severity
70.0×40%
Refusal Volume
35.3×30%
Recency
0.0×20%
Frequency
11.3×10%
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
3/25/2010
80LYYGLOVE, PATIENT EXAMINATION, LATEX
477HOLES
Los Angeles District Office (LOS-DO)
12/14/2006
80LYYGLOVE, PATIENT EXAMINATION, LATEX
477HOLES
Philadelphia District Office (PHI-DO)
12/14/2006
80LYYGLOVE, PATIENT EXAMINATION, LATEX
477HOLES
Philadelphia District Office (PHI-DO)
11/10/2005
80LYYGLOVE, PATIENT EXAMINATION, LATEX
477HOLES
Philadelphia District Office (PHI-DO)
11/10/2005
80LYYGLOVE, PATIENT EXAMINATION, LATEX
477HOLES
Philadelphia District Office (PHI-DO)
8/20/2003
80LYYGLOVE, PATIENT EXAMINATION, LATEX
477HOLES
Philadelphia District Office (PHI-DO)
8/20/2003
80LYYGLOVE, PATIENT EXAMINATION, LATEX
477HOLES
Philadelphia District Office (PHI-DO)
3/6/2003
80LYYGLOVE, PATIENT EXAMINATION, LATEX
477HOLES
Philadelphia District Office (PHI-DO)

Frequently Asked Questions

What is Marcon Rubber Industry's FDA import refusal history?

Marcon Rubber Industry (FEI: 3183) has 8 FDA import refusal record(s) in our database, spanning from 3/6/2003 to 3/25/2010.

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. Marcon Rubber Industry's FEI number is 3183.

What types of violations has Marcon Rubber Industry received?

Marcon Rubber Industry 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 Marcon Rubber Industry come from?

All FDA import refusal data for Marcon Rubber Industry 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.