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Arata Corporation

✅ Low Risk

FEI: 3004621188 • Nagoya, Aichi • JAPAN

FEI

FEI Number

3004621188

📍

Location

Nagoya, Aichi

🇯🇵

Country

JAPAN
🏢

Address

Ohsu 1-21-10, Nakasu-Cho; Nakagawa, Nagoya, Aichi, Japan

Low Risk

FDA Import Risk Assessment

24.4
LowModerateHighCritical

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

Statistics

3
Total Refusals
2
Unique Violations
12/29/2004
Latest Refusal
12/29/2004
Earliest Refusal

Score Breakdown

Violation Severity
36.7×40%
Refusal Volume
22.3×30%
Recency
0.0×20%
Frequency
30.0×10%
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

3412×

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).

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
12/29/2004
76EFWTOOTHBRUSH, MANUAL
341REGISTERED
Los Angeles District Office (LOS-DO)
12/29/2004
76EFWTOOTHBRUSH, MANUAL
341REGISTERED
Los Angeles District Office (LOS-DO)
12/29/2004
63RBY04SODIUM FLUORIDE (DENTAL CARIES PROPHYLACTIC)
118NOT LISTED
Los Angeles District Office (LOS-DO)

Frequently Asked Questions

What is Arata Corporation's FDA import refusal history?

Arata Corporation (FEI: 3004621188) has 3 FDA import refusal record(s) in our database, spanning from 12/29/2004 to 12/29/2004.

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. Arata Corporation's FEI number is 3004621188.

What types of violations has Arata Corporation received?

Arata 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 Arata Corporation come from?

All FDA import refusal data for Arata 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.