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IWAKI SHOTEN CO.,LTD.

⚠️ High Risk

FEI: 2000013467 • Kobe, Hyogo • JAPAN

FEI

FEI Number

2000013467

📍

Location

Kobe, Hyogo

🇯🇵

Country

JAPAN
🏢

Address

Kobe Chuooroshiuribanai 1-1, Nakanoshima; Hyogo, Kobe, Hyogo, Japan

High Risk

FDA Import Risk Assessment

58.0
LowModerateHighCritical

This firm has a significant history of FDA import refusals with notable violations.

Statistics

11
Total Refusals
1
Unique Violations
11/16/2012
Latest Refusal
10/13/2011
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
Refusal Volume
40.0×30%
Recency
0.0×20%
Frequency
100.0×10%
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

30811×

MFR INSAN

The article is subject to refusal of admission pursuant to section 801(a)(1) in that the article appears to have been manufactured, processed, or packed under insanitary conditions.

Refusal History

DateProductViolationsDivision
11/16/2012
16AGH01ANCHOVY
308MFR INSAN
Los Angeles District Office (LOS-DO)
11/16/2012
16AGH01ANCHOVY
308MFR INSAN
Los Angeles District Office (LOS-DO)
11/16/2012
16AGH01ANCHOVY
308MFR INSAN
Los Angeles District Office (LOS-DO)
11/16/2012
16AGH01ANCHOVY
308MFR INSAN
Los Angeles District Office (LOS-DO)
11/16/2012
16AGH01ANCHOVY
308MFR INSAN
Los Angeles District Office (LOS-DO)
10/17/2012
16AGH33SARDINES (BRISLING, SPRATS, PILCHARDS, ETC.)
308MFR INSAN
Los Angeles District Office (LOS-DO)
5/7/2012
16AGH33SARDINES (BRISLING, SPRATS, PILCHARDS, ETC.)
308MFR INSAN
San Francisco District Office (SAN-DO)
5/1/2012
16AGH33SARDINES (BRISLING, SPRATS, PILCHARDS, ETC.)
308MFR INSAN
San Francisco District Office (SAN-DO)
1/10/2012
16AGH33SARDINES (BRISLING, SPRATS, PILCHARDS, ETC.)
308MFR INSAN
Los Angeles District Office (LOS-DO)
10/13/2011
16AGH33SARDINES (BRISLING, SPRATS, PILCHARDS, ETC.)
308MFR INSAN
Los Angeles District Office (LOS-DO)
10/13/2011
16AGH33SARDINES (BRISLING, SPRATS, PILCHARDS, ETC.)
308MFR INSAN
Los Angeles District Office (LOS-DO)

Frequently Asked Questions

What is IWAKI SHOTEN CO.,LTD.'s FDA import refusal history?

IWAKI SHOTEN CO.,LTD. (FEI: 2000013467) has 11 FDA import refusal record(s) in our database, spanning from 10/13/2011 to 11/16/2012.

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. IWAKI SHOTEN CO.,LTD.'s FEI number is 2000013467.

What types of violations has IWAKI SHOTEN CO.,LTD. received?

IWAKI SHOTEN CO.,LTD. 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 IWAKI SHOTEN CO.,LTD. come from?

All FDA import refusal data for IWAKI SHOTEN 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.