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Copioumed International Inc. (Offfice)

⚠️ Moderate Risk

FEI: 3001581543 • Taipei • TAIWAN

FEI

FEI Number

3001581543

📍

Location

Taipei

🇹🇼

Country

TAIWAN
🏢

Address

No. 169-12 Sec 2, 6f-1; Chang An E Road, Taipei, , Taiwan

Moderate Risk

FDA Import Risk Assessment

33.6
LowModerateHighCritical

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

Statistics

2
Total Refusals
1
Unique Violations
9/19/2007
Latest Refusal
10/16/2001
Earliest Refusal

Score Breakdown

Violation Severity
70.0×40%
Refusal Volume
17.7×30%
Recency
0.0×20%
Frequency
3.4×10%
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

4772×

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
9/19/2007
79KGOSURGEON'S GLOVES
477HOLES
Chicago District Office (CHI-DO)
10/16/2001
80LYZGLOVE, PATIENT EXAMINATION, VINYL
477HOLES
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is Copioumed International Inc. (Offfice)'s FDA import refusal history?

Copioumed International Inc. (Offfice) (FEI: 3001581543) has 2 FDA import refusal record(s) in our database, spanning from 10/16/2001 to 9/19/2007.

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. Copioumed International Inc. (Offfice)'s FEI number is 3001581543.

What types of violations has Copioumed International Inc. (Offfice) received?

Copioumed International Inc. (Offfice) 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 Copioumed International Inc. (Offfice) come from?

All FDA import refusal data for Copioumed International Inc. (Offfice) 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.