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Citizen Systems Japan Co., Ltd

✅ Low Risk

FEI: 3005176386 • Tokyo, Nishi-Tokyo-shi • JAPAN

FEI

FEI Number

3005176386

📍

Location

Tokyo, Nishi-Tokyo-shi

🇯🇵

Country

JAPAN
🏢

Address

6-1-12, Tanashi-cho, , Tokyo, Nishi-Tokyo-shi, Japan

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
10/18/2010
Latest Refusal
10/18/2010
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
10/18/2010
74DXNSYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE
341REGISTERED
Florida District Office (FLA-DO)

Frequently Asked Questions

What is Citizen Systems Japan Co., Ltd's FDA import refusal history?

Citizen Systems Japan Co., Ltd (FEI: 3005176386) has 1 FDA import refusal record(s) in our database, spanning from 10/18/2010 to 10/18/2010.

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. Citizen Systems Japan Co., Ltd's FEI number is 3005176386.

What types of violations has Citizen Systems Japan Co., Ltd received?

Citizen Systems Japan 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 Citizen Systems Japan Co., Ltd come from?

All FDA import refusal data for Citizen Systems Japan 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.