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TOKYO NIITAKAYA CO. LTD.

⚠️ Moderate Risk

FEI: 3012222460 • Chuo, Tokyo • JAPAN

FEI

FEI Number

3012222460

📍

Location

Chuo, Tokyo

🇯🇵

Country

JAPAN
🏢

Address

Nihonba 3-2-2, Nihonbashihama-Cho, Chuo, Tokyo, Japan

Moderate Risk

FDA Import Risk Assessment

36.2
LowModerateHighCritical

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

Statistics

1
Total Refusals
4
Unique Violations
6/10/2022
Latest Refusal
6/10/2022
Earliest Refusal

Score Breakdown

Violation Severity
72.5×40%
Refusal Volume
11.2×30%
Recency
14.2×20%
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

111×

UNSAFE COL

The article appears to be, or to bear or contain a color additive which is unsafe within the meaning of Section 721(a).

2741×

COLOR LBLG

The article appears to contain an artificial coloring and it fails to bear labeling stating that fact.

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).

831×

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.

Refusal History

DateProductViolationsDivision
6/10/2022
28AGY19GINGER, WHOLE (SPICE)
11UNSAFE COL
274COLOR LBLG
62NEEDS FCE
83NO PROCESS
Division of West Coast Imports (DWCI)

Frequently Asked Questions

What is TOKYO NIITAKAYA CO. LTD.'s FDA import refusal history?

TOKYO NIITAKAYA CO. LTD. (FEI: 3012222460) has 1 FDA import refusal record(s) in our database, spanning from 6/10/2022 to 6/10/2022.

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. TOKYO NIITAKAYA CO. LTD.'s FEI number is 3012222460.

What types of violations has TOKYO NIITAKAYA CO. LTD. received?

TOKYO NIITAKAYA CO. LTD. has been cited for 4 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 TOKYO NIITAKAYA CO. LTD. come from?

All FDA import refusal data for TOKYO NIITAKAYA CO. LTD. 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.