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KANEKA MEDIX CORPORATION KANAGAWA PLANT

✅ Low Risk

FEI: 3009761573 • Ashigarakami-Gun, Kanagawa • JAPAN

FEI

FEI Number

3009761573

📍

Location

Ashigarakami-Gun, Kanagawa

🇯🇵

Country

JAPAN
🏢

Address

Azadeguchi 225-1, Yamakita; Yamakita-Machi, Ashigarakami-Gun, Kanagawa, Japan

Low Risk

FDA Import Risk Assessment

24.3
LowModerateHighCritical

This firm has a minimal history of FDA import refusals with low-severity violations.

Statistics

1
Total Refusals
1
Unique Violations
4/17/2020
Latest Refusal
4/17/2020
Earliest Refusal

Score Breakdown

Violation Severity
50.0×40%
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

1181×

NOT LISTED

It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).

Refusal History

DateProductViolationsDivision
4/17/2020
74DQYCATHETER, PERCUTANEOUS
118NOT LISTED
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is KANEKA MEDIX CORPORATION KANAGAWA PLANT's FDA import refusal history?

KANEKA MEDIX CORPORATION KANAGAWA PLANT (FEI: 3009761573) has 1 FDA import refusal record(s) in our database, spanning from 4/17/2020 to 4/17/2020.

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. KANEKA MEDIX CORPORATION KANAGAWA PLANT's FEI number is 3009761573.

What types of violations has KANEKA MEDIX CORPORATION KANAGAWA PLANT received?

KANEKA MEDIX CORPORATION KANAGAWA PLANT 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 KANEKA MEDIX CORPORATION KANAGAWA PLANT come from?

All FDA import refusal data for KANEKA MEDIX CORPORATION KANAGAWA PLANT 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.