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Nichia Corporation

⚠️ Moderate Risk

FEI: 3008798251 • Anan, Tokushima • JAPAN

FEI

FEI Number

3008798251

📍

Location

Anan, Tokushima

🇯🇵

Country

JAPAN
🏢

Address

491 OKA, Kaminaka-Cho, Anan, Tokushima, Japan

Moderate Risk

FDA Import Risk Assessment

33.6
LowModerateHighCritical

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

Statistics

2
Total Refusals
2
Unique Violations
1/7/2003
Latest Refusal
10/22/2001
Earliest Refusal

Score Breakdown

Violation Severity
66.7×40%
Refusal Volume
17.7×30%
Recency
0.0×20%
Frequency
16.5×10%
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

472×

NON STD

The article is subject to refusal of admission pursuant to section 536(a) of the Federal Food, Drug, and Cosmetic Act (FFDCA) in that it appears to be an electronic product offered for importation into the United States which fails to comply with an applicable standard prescribed pursuant to section 534 of the FFDCA.

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
1/7/2003
95L22LASER PRODUCT FOR NON-MEDICAL USE
47NON STD
Southwest Import District Office (SWI-DO)
10/22/2001
95L22LASER PRODUCT FOR NON-MEDICAL USE
47NON STD
476NO REGISTR
San Francisco District Office (SAN-DO)

Frequently Asked Questions

What is Nichia Corporation's FDA import refusal history?

Nichia Corporation (FEI: 3008798251) has 2 FDA import refusal record(s) in our database, spanning from 10/22/2001 to 1/7/2003.

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. Nichia Corporation's FEI number is 3008798251.

What types of violations has Nichia Corporation received?

Nichia Corporation has been cited for 2 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 Nichia Corporation come from?

All FDA import refusal data for Nichia Corporation 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.