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Nihon Tabako Sangyo

⚠️ Moderate Risk

FEI: 3002265227 • Minato, Tokyo • JAPAN

FEI

FEI Number

3002265227

📍

Location

Minato, Tokyo

🇯🇵

Country

JAPAN
🏢

Address

2 Chome 2-1, Toranomon, Minato, Tokyo, Japan

Moderate Risk

FDA Import Risk Assessment

42.8
LowModerateHighCritical

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

Statistics

6
Total Refusals
3
Unique Violations
1/18/2002
Latest Refusal
1/18/2002
Earliest Refusal

Score Breakdown

Violation Severity
68.6×40%
Refusal Volume
31.3×30%
Recency
0.0×20%
Frequency
60.0×10%
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

836×

NO PROCESS

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the manufacturer's failure to file a scheduled process demonstrates that the product is not being manufactured under the mandatory provisions of 21 CFR Part 108 and therefore appears to have been manufactured, processed, or packed, under insanitary conditions whereby it may have been rendered injurious to health.

3284×

USUAL NAME

The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(i)(1) of the FD&C Act in that the label fails to bear the common or usual name of the food, if any there be.

624×

NEEDS FCE

It appears the manufacturer is not registered as a low acid canned food or acidified food manufacturer pursuant to 21 CFR 108.25(c)(1) or 108.35(c)(1).

Refusal History

DateProductViolationsDivision
1/18/2002
31KGT02TEA, GREEN
328USUAL NAME
62NEEDS FCE
83NO PROCESS
Los Angeles District Office (LOS-DO)
1/18/2002
31KGT02TEA, GREEN
328USUAL NAME
62NEEDS FCE
83NO PROCESS
Los Angeles District Office (LOS-DO)
1/18/2002
31KGT02TEA, GREEN
328USUAL NAME
62NEEDS FCE
83NO PROCESS
Los Angeles District Office (LOS-DO)
1/18/2002
31KGT02TEA, GREEN
328USUAL NAME
62NEEDS FCE
83NO PROCESS
Los Angeles District Office (LOS-DO)
1/18/2002
31KGT02TEA, GREEN
83NO PROCESS
Los Angeles District Office (LOS-DO)
1/18/2002
31KGT02TEA, GREEN
83NO PROCESS
Los Angeles District Office (LOS-DO)

Frequently Asked Questions

What is Nihon Tabako Sangyo's FDA import refusal history?

Nihon Tabako Sangyo (FEI: 3002265227) has 6 FDA import refusal record(s) in our database, spanning from 1/18/2002 to 1/18/2002.

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. Nihon Tabako Sangyo's FEI number is 3002265227.

What types of violations has Nihon Tabako Sangyo received?

Nihon Tabako Sangyo has been cited for 3 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 Nihon Tabako Sangyo come from?

All FDA import refusal data for Nihon Tabako Sangyo 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.