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Hartalega Sdn. Bhd.

⚠️ Moderate Risk

FEI: 3872 • Kuala Lumpur, Wilayah Persekutuan • MALAYSIA

FEI

FEI Number

3872

📍

Location

Kuala Lumpur, Wilayah Persekutuan

🇲🇾

Country

MALAYSIA
🏢

Address

Lot 9, Taman Kepong Industrial Estates, Jalan Kuang Bulan, Kuala Lumpur, Wilayah Persekutuan, Malaysia

Moderate Risk

FDA Import Risk Assessment

28.1
LowModerateHighCritical

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

Statistics

6
Total Refusals
2
Unique Violations
11/9/2010
Latest Refusal
5/14/2009
Earliest Refusal

Score Breakdown

Violation Severity
36.7×40%
Refusal Volume
31.3×30%
Recency
0.0×20%
Frequency
40.3×10%
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

3415×

REGISTERED

It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).

4771×

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
11/9/2010
80FMCGLOVE, PATIENT EXAMINATION
341REGISTERED
New York District Office (NYK-DO)
11/9/2010
80FMCGLOVE, PATIENT EXAMINATION
341REGISTERED
New York District Office (NYK-DO)
11/9/2010
80FMCGLOVE, PATIENT EXAMINATION
341REGISTERED
New York District Office (NYK-DO)
11/9/2010
80FMCGLOVE, PATIENT EXAMINATION
341REGISTERED
New York District Office (NYK-DO)
11/9/2010
80FMCGLOVE, PATIENT EXAMINATION
341REGISTERED
New York District Office (NYK-DO)
5/14/2009
80LYYGLOVE, PATIENT EXAMINATION, LATEX
477HOLES
Los Angeles District Office (LOS-DO)

Frequently Asked Questions

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

Hartalega Sdn. Bhd. (FEI: 3872) has 6 FDA import refusal record(s) in our database, spanning from 5/14/2009 to 11/9/2010.

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. Hartalega Sdn. Bhd.'s FEI number is 3872.

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

Hartalega Sdn. Bhd. has been cited for 2 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 Hartalega Sdn. Bhd. come from?

All FDA import refusal data for Hartalega 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.