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Shiraishi (Malaysia) Sdn. Bhd.

⚠️ Moderate Risk

FEI: 3003534526 • Darul Ehsan • MALAYSIA

FEI

FEI Number

3003534526

📍

Location

Darul Ehsan

🇲🇾

Country

MALAYSIA
🏢

Address

17-3 Jalan 14/22, The Right Angle, 46100 Petaling Jaya, Darul Ehsan, , Malaysia

Moderate Risk

FDA Import Risk Assessment

26.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
2
Unique Violations
3/21/2003
Latest Refusal
3/21/2003
Earliest Refusal

Score Breakdown

Violation Severity
55.0×40%
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

3351×

LACKS N/C

The article is in package form and appears to not have a label containing an accurate statement of the quantity of the contents in terms of weight, measure or numerical count and no variations or exemptions have been prescribed by regs.

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
3/21/2003
80LYYGLOVE, PATIENT EXAMINATION, LATEX
335LACKS N/C
477HOLES
Seattle District Office (SEA-DO)

Frequently Asked Questions

What is Shiraishi (Malaysia) Sdn. Bhd.'s FDA import refusal history?

Shiraishi (Malaysia) Sdn. Bhd. (FEI: 3003534526) has 1 FDA import refusal record(s) in our database, spanning from 3/21/2003 to 3/21/2003.

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. Shiraishi (Malaysia) Sdn. Bhd.'s FEI number is 3003534526.

What types of violations has Shiraishi (Malaysia) Sdn. Bhd. received?

Shiraishi (Malaysia) 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 Shiraishi (Malaysia) Sdn. Bhd. come from?

All FDA import refusal data for Shiraishi (Malaysia) 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.