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Bard Sdn. Bhd.

⚠️ Moderate Risk

FEI: 3002806591 • Kulim, Kedah • MALAYSIA

FEI

FEI Number

3002806591

📍

Location

Kulim, Kedah

🇲🇾

Country

MALAYSIA
🏢

Address

Lot 57C, Kulim Industrial Estate, Lorong Perusahaan 5, Kulim, Kedah, Malaysia

Moderate Risk

FDA Import Risk Assessment

32.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
9/3/2019
Latest Refusal
9/3/2019
Earliest Refusal

Score Breakdown

Violation Severity
70.0×40%
Refusal Volume
11.2×30%
Recency
0.0×20%
Frequency
10.0×10%
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

4791×

DV QUALITY

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be adulterated since its strength differs from, or its purity or quality falls below, that which it purports or is represented to possess.

Refusal History

DateProductViolationsDivision
9/3/2019
78MJCCATHETER, UROLOGICAL (ANTIMICROBIAL) AND ACCESSORIES
479DV QUALITY
Division of Southwest Imports (DSWI)

Frequently Asked Questions

What is Bard Sdn. Bhd.'s FDA import refusal history?

Bard Sdn. Bhd. (FEI: 3002806591) has 1 FDA import refusal record(s) in our database, spanning from 9/3/2019 to 9/3/2019.

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. Bard Sdn. Bhd.'s FEI number is 3002806591.

What types of violations has Bard Sdn. Bhd. received?

Bard Sdn. Bhd. 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 Bard Sdn. Bhd. come from?

All FDA import refusal data for Bard Sdn. Bhd. 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.