HACHINOHE KANZUME CO,LTD HQ FACTORY

⚠️ Moderate Risk

FEI: 3004254318 • Hachinohe, Aomori • JAPAN

FEI

FEI Number

3004254318

📍

Location

Hachinohe, Aomori

🇯🇵

Country

JAPAN

🏢

Address

48-1, Oazaichikawa-Machi, Hachinohe, Aomori, Japan

Moderate Risk

FDA Import Risk Assessment

44.5

LowModerateHighCritical

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

Statistics

Total Refusals

Unique Violations

6/27/2007

Latest Refusal

8/17/2004

Earliest Refusal

Score Breakdown

Violation Severity

80.0×40%

Refusal Volume

33.5×30%

Recency

0.0×20%

Frequency

24.5×10%

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

Violation Summary

837×

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.

625×

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

Date	Product	Violations	Division
6/27/2007	16MET03SQUID, OTHER AQUATIC SPECIES	83NO PROCESS	San Francisco District Office (SAN-DO)
6/27/2007	16MET03SQUID, OTHER AQUATIC SPECIES	83NO PROCESS	San Francisco District Office (SAN-DO)
6/27/2007	16EET02CLAMS	62NEEDS FCE 83NO PROCESS	San Francisco District Office (SAN-DO)
2/5/2007	16MET03SQUID, OTHER AQUATIC SPECIES	62NEEDS FCE 83NO PROCESS	San Francisco District Office (SAN-DO)
2/5/2007	16EET02CLAMS	62NEEDS FCE 83NO PROCESS	San Francisco District Office (SAN-DO)
8/17/2004	16AEE73MACKEREL (ALL EXCEPT SCOMBEROMORUS SP, EG SPANISH OR KING SEE '22')	62NEEDS FCE 83NO PROCESS	Los Angeles District Office (LOS-DO)
8/17/2004	16AEE33SARDINES (BRISLING, SPRATS, PILCHARDS, ETC.)	62NEEDS FCE 83NO PROCESS	Los Angeles District Office (LOS-DO)

Frequently Asked Questions

What is HACHINOHE KANZUME CO,LTD HQ FACTORY's FDA import refusal history?

HACHINOHE KANZUME CO,LTD HQ FACTORY (FEI: 3004254318) has 7 FDA import refusal record(s) in our database, spanning from 8/17/2004 to 6/27/2007.

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. HACHINOHE KANZUME CO,LTD HQ FACTORY's FEI number is 3004254318.

What types of violations has HACHINOHE KANZUME CO,LTD HQ FACTORY received?

HACHINOHE KANZUME CO,LTD HQ FACTORY 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 HACHINOHE KANZUME CO,LTD HQ FACTORY come from?

All FDA import refusal data for HACHINOHE KANZUME CO,LTD HQ 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.