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Polycore Optical (M) Sdn Bhd

⚠️ Moderate Risk

FEI: 1000268442 • Senai, Johor • MALAYSIA

FEI

FEI Number

1000268442

📍

Location

Senai, Johor

🇲🇾

Country

MALAYSIA
🏢

Address

Lot Plo 23, Kawasan, Perindustrian Senai, Senai, Johor, Malaysia

Moderate Risk

FDA Import Risk Assessment

28.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
5/8/2013
Latest Refusal
5/8/2013
Earliest Refusal

Score Breakdown

Violation Severity
60.0×40%
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

2311×

LENS CERT

The lenses are declared by accompanying certificate to meet the requirements for impact-resistant lenses in 21 CFR 801.410 but does not appear to be impact-resistant.

Refusal History

DateProductViolationsDivision
5/8/2013
86HQGLENS, SPECTACLE, NON-CUSTOM (PRESCRIPTION)
231LENS CERT
Los Angeles District Office (LOS-DO)

Frequently Asked Questions

What is Polycore Optical (M) Sdn Bhd's FDA import refusal history?

Polycore Optical (M) Sdn Bhd (FEI: 1000268442) has 1 FDA import refusal record(s) in our database, spanning from 5/8/2013 to 5/8/2013.

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. Polycore Optical (M) Sdn Bhd's FEI number is 1000268442.

What types of violations has Polycore Optical (M) Sdn Bhd received?

Polycore Optical (M) 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 Polycore Optical (M) Sdn Bhd come from?

All FDA import refusal data for Polycore Optical (M) 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.