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Opto Electronics

⚠️ Moderate Risk

FEI: 3007152715 • Saitama-Pref • JAPAN

FEI

FEI Number

3007152715

📍

Location

Saitama-Pref

🇯🇵

Country

JAPAN
🏢

Address

12-17 Tsukagoshi, , Saitama-Pref, , Japan

Moderate Risk

FDA Import Risk Assessment

36.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
9/7/2011
Latest Refusal
9/7/2011
Earliest Refusal

Score Breakdown

Violation Severity
80.0×40%
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

1261×

FAILS STD

The article appears to be a device which is subject to a performance standard established under Section 514 and does not appear to be in all respects in conformity with such standard.

Refusal History

DateProductViolationsDivision
9/7/2011
95RFZUPC READER (BAR CODE RECORDER), UTILITY/PERIPHERAL LASER PRODUCTS
126FAILS STD
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is Opto Electronics's FDA import refusal history?

Opto Electronics (FEI: 3007152715) has 1 FDA import refusal record(s) in our database, spanning from 9/7/2011 to 9/7/2011.

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. Opto Electronics's FEI number is 3007152715.

What types of violations has Opto Electronics received?

Opto Electronics 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 Opto Electronics come from?

All FDA import refusal data for Opto Electronics 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.