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Murai Optical Singapore Pte Ltd

✅ Low Risk

FEI: 3004469179 • Singapore • SINGAPORE

FEI

FEI Number

3004469179

📍

Location

Singapore

🇸🇬

Country

SINGAPORE
🏢

Address

1 King Georges Avenue 03-00, , Singapore, , Singapore

Low Risk

FDA Import Risk Assessment

24.3
LowModerateHighCritical

This firm has a minimal history of FDA import refusals with low-severity violations.

Statistics

1
Total Refusals
1
Unique Violations
8/31/2004
Latest Refusal
8/31/2004
Earliest Refusal

Score Breakdown

Violation Severity
50.0×40%
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

1181×

NOT LISTED

It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).

Refusal History

DateProductViolationsDivision
8/31/2004
86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)
118NOT LISTED
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is Murai Optical Singapore Pte Ltd's FDA import refusal history?

Murai Optical Singapore Pte Ltd (FEI: 3004469179) has 1 FDA import refusal record(s) in our database, spanning from 8/31/2004 to 8/31/2004.

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. Murai Optical Singapore Pte Ltd's FEI number is 3004469179.

What types of violations has Murai Optical Singapore Pte Ltd received?

Murai Optical Singapore Pte Ltd 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 Murai Optical Singapore Pte Ltd come from?

All FDA import refusal data for Murai Optical Singapore Pte Ltd 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.