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Japan Inc Health Support

✅ Low Risk

FEI: 3009318401 • Minamimatsuura-gun, Nagasaki-ken • JAPAN

FEI

FEI Number

3009318401

📍

Location

Minamimatsuura-gun, Nagasaki-ken

🇯🇵

Country

JAPAN
🏢

Address

7-5-9 Nishi Shinjuku, , Minamimatsuura-gun, Nagasaki-ken, Japan

Low Risk

FDA Import Risk Assessment

20.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
2
Unique Violations
2/21/2012
Latest Refusal
2/21/2012
Earliest Refusal

Score Breakdown

Violation Severity
40.0×40%
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).

32601×

NO ENGLISH

Required label or labeling appears to not be in English in violation of 21 C.F.R. 801.15(c)(1)

Refusal History

DateProductViolationsDivision
2/21/2012
76EFWTOOTHBRUSH, MANUAL
118NOT LISTED
3260NO ENGLISH
Cincinnati District Office (CIN-DO)

Frequently Asked Questions

What is Japan Inc Health Support's FDA import refusal history?

Japan Inc Health Support (FEI: 3009318401) has 1 FDA import refusal record(s) in our database, spanning from 2/21/2012 to 2/21/2012.

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. Japan Inc Health Support's FEI number is 3009318401.

What types of violations has Japan Inc Health Support received?

Japan Inc Health Support 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 Japan Inc Health Support come from?

All FDA import refusal data for Japan Inc Health Support 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.