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NANSHIN TSUKEMONO CO., LTD.

⚠️ Moderate Risk

FEI: 3004305924 • Iida, Nagano • JAPAN

FEI

FEI Number

3004305924

📍

Location

Iida, Nagano

🇯🇵

Country

JAPAN
🏢

Address

7660, Matsuomyo, Iida, Nagano, Japan

Moderate Risk

FDA Import Risk Assessment

38.9
LowModerateHighCritical

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

Statistics

2
Total Refusals
3
Unique Violations
11/27/2007
Latest Refusal
6/16/2004
Earliest Refusal

Score Breakdown

Violation Severity
82.5×40%
Refusal Volume
17.7×30%
Recency
0.0×20%
Frequency
5.8×10%
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

622×

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).

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).

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
11/27/2007
25NGT22BURDOCK, GOBO, WITH SAUCE
62NEEDS FCE
83NO PROCESS
San Francisco District Office (SAN-DO)
6/16/2004
25JVF22BURDOCK, GOBO (ROOT & TUBER VEGETABLE)
11UNSAFE COL
62NEEDS FCE
Los Angeles District Office (LOS-DO)

Frequently Asked Questions

What is NANSHIN TSUKEMONO CO., LTD.'s FDA import refusal history?

NANSHIN TSUKEMONO CO., LTD. (FEI: 3004305924) has 2 FDA import refusal record(s) in our database, spanning from 6/16/2004 to 11/27/2007.

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. NANSHIN TSUKEMONO CO., LTD.'s FEI number is 3004305924.

What types of violations has NANSHIN TSUKEMONO CO., LTD. received?

NANSHIN TSUKEMONO CO., LTD. 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 NANSHIN TSUKEMONO CO., LTD. come from?

All FDA import refusal data for NANSHIN TSUKEMONO 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.