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Shimadzu Corporation

⚠️ Moderate Risk

FEI: 1000228296 • Chiyoda Ku, Tokyo • JAPAN

FEI

FEI Number

1000228296

📍

Location

Chiyoda Ku, Tokyo

🇯🇵

Country

JAPAN
🏢

Address

3, Kanda-Nishikicho 1-Chome Chiyoda-Ku, , Chiyoda Ku, Tokyo, Japan

Moderate Risk

FDA Import Risk Assessment

35.3
LowModerateHighCritical

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

Statistics

2
Total Refusals
1
Unique Violations
12/6/2007
Latest Refusal
12/6/2007
Earliest Refusal

Score Breakdown

Violation Severity
70.0×40%
Refusal Volume
17.7×30%
Recency
0.0×20%
Frequency
20.0×10%
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

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.

Refusal History

DateProductViolationsDivision
12/6/2007
90KPSSYSTEM, TOMOGRAPHY, COMPUTED, EMISSION
47NON STD
Florida District Office (FLA-DO)
12/6/2007
90JAKSYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
47NON STD
Florida District Office (FLA-DO)

Frequently Asked Questions

What is Shimadzu Corporation's FDA import refusal history?

Shimadzu Corporation (FEI: 1000228296) has 2 FDA import refusal record(s) in our database, spanning from 12/6/2007 to 12/6/2007.

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. Shimadzu Corporation's FEI number is 1000228296.

What types of violations has Shimadzu Corporation received?

Shimadzu Corporation 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 Shimadzu Corporation come from?

All FDA import refusal data for Shimadzu 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.