ImportRefusal LogoImportRefusal

Essilor Manufacturing (Thailand) Co. Ltd.

✅ Low Risk

FEI: 1000178824 • Lat Krabang, Bangkok • THAILAND

FEI

FEI Number

1000178824

📍

Location

Lat Krabang, Bangkok

🇹🇭

Country

THAILAND
🏢

Address

Lat Krabang Ind. Estate E.p.z. Phase, Iii, 213 Chalongkrung Rd., Lamplatview, Lat Krabang, Bangkok, Thailand

Low Risk

FDA Import Risk Assessment

16.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
12/3/2010
Latest Refusal
12/3/2010
Earliest Refusal

Score Breakdown

Violation Severity
30.0×40%
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

3411×

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).

Refusal History

DateProductViolationsDivision
12/3/2010
86HQGLENS, SPECTACLE, NON-CUSTOM (PRESCRIPTION)
341REGISTERED
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is Essilor Manufacturing (Thailand) Co. Ltd.'s FDA import refusal history?

Essilor Manufacturing (Thailand) Co. Ltd. (FEI: 1000178824) has 1 FDA import refusal record(s) in our database, spanning from 12/3/2010 to 12/3/2010.

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. Essilor Manufacturing (Thailand) Co. Ltd.'s FEI number is 1000178824.

What types of violations has Essilor Manufacturing (Thailand) Co. Ltd. received?

Essilor Manufacturing (Thailand) Co. 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 Essilor Manufacturing (Thailand) Co. Ltd. come from?

All FDA import refusal data for Essilor Manufacturing (Thailand) Co. 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.