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Houkou, Inc., Hachinohe Plant

⚠️ Moderate Risk

FEI: 3004294502 • Hachinohe, Aomori • JAPAN

FEI

FEI Number

3004294502

📍

Location

Hachinohe, Aomori

🇯🇵

Country

JAPAN
🏢

Address

Azashiribikimaeyama 31-203, Oazaichikawa-Machi, Hachinohe, Aomori, Japan

Moderate Risk

FDA Import Risk Assessment

39.1
LowModerateHighCritical

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

Statistics

2
Total Refusals
2
Unique Violations
4/10/2006
Latest Refusal
3/4/2005
Earliest Refusal

Score Breakdown

Violation Severity
80.0×40%
Refusal Volume
17.7×30%
Recency
0.0×20%
Frequency
18.2×10%
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).

832×

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
4/10/2006
16JGT01CRAB
62NEEDS FCE
83NO PROCESS
San Francisco District Office (SAN-DO)
3/4/2005
16JET01CRAB
62NEEDS FCE
83NO PROCESS
San Francisco District Office (SAN-DO)

Frequently Asked Questions

What is Houkou, Inc., Hachinohe Plant's FDA import refusal history?

Houkou, Inc., Hachinohe Plant (FEI: 3004294502) has 2 FDA import refusal record(s) in our database, spanning from 3/4/2005 to 4/10/2006.

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. Houkou, Inc., Hachinohe Plant's FEI number is 3004294502.

What types of violations has Houkou, Inc., Hachinohe Plant received?

Houkou, Inc., Hachinohe Plant has been cited for 2 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 Houkou, Inc., Hachinohe Plant come from?

All FDA import refusal data for Houkou, Inc., Hachinohe Plant 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.