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TableMark. Co., Ltd. Niigata Factory

⚠️ Moderate Risk

FEI: 3011861834 • Minamiuonuma, Niigata • JAPAN

FEI

FEI Number

3011861834

📍

Location

Minamiuonuma, Niigata

🇯🇵

Country

JAPAN
🏢

Address

813-3, Nagasaki, Minamiuonuma, Niigata, Japan

Moderate Risk

FDA Import Risk Assessment

36.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
5/1/2015
Latest Refusal
5/1/2015
Earliest Refusal

Score Breakdown

Violation Severity
80.0×40%
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

621×

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
5/1/2015
02DGT02RICE, PLAIN (WHITE OR POLISHED) PROCESSED (PACKAGED)
62NEEDS FCE
Los Angeles District Office (LOS-DO)

Frequently Asked Questions

What is TableMark. Co., Ltd. Niigata Factory's FDA import refusal history?

TableMark. Co., Ltd. Niigata Factory (FEI: 3011861834) has 1 FDA import refusal record(s) in our database, spanning from 5/1/2015 to 5/1/2015.

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. TableMark. Co., Ltd. Niigata Factory's FEI number is 3011861834.

What types of violations has TableMark. Co., Ltd. Niigata Factory received?

TableMark. Co., Ltd. Niigata Factory 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 TableMark. Co., Ltd. Niigata Factory come from?

All FDA import refusal data for TableMark. Co., Ltd. Niigata Factory 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.