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OCLARO JAPAN

⚠️ Moderate Risk

FEI: 3018450325 • Klonglung • THAILAND

FEI

FEI Number

3018450325

📍

Location

Klonglung

🇹🇭

Country

THAILAND
🏢

Address

5/6 Moo 9 Soi Khunp, , Klonglung, , Thailand

Moderate Risk

FDA Import Risk Assessment

32.2
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
9/8/2022
Latest Refusal
9/8/2022
Earliest Refusal

Score Breakdown

Violation Severity
60.0×40%
Refusal Volume
11.2×30%
Recency
19.1×20%
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

4761×

NO REGISTR

The article appears to be an electronic product that does not comply with an applicable standard as prescribed by Section 534 because no reporting has been provided as required by Section 537(b).

Refusal History

DateProductViolationsDivision
9/8/2022
95RFNFIBER OPTIC COMMUNICATION AND DATA TRANSFER, LASER
476NO REGISTR
Division of Southwest Imports (DSWI)

Frequently Asked Questions

What is OCLARO JAPAN's FDA import refusal history?

OCLARO JAPAN (FEI: 3018450325) has 1 FDA import refusal record(s) in our database, spanning from 9/8/2022 to 9/8/2022.

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. OCLARO JAPAN's FEI number is 3018450325.

What types of violations has OCLARO JAPAN received?

OCLARO JAPAN 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 OCLARO JAPAN come from?

All FDA import refusal data for OCLARO JAPAN 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.