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Azuma Foods Co., Ltd.

⚠️ Moderate Risk

FEI: 3004262335 • Mie-Gun, MIE • JAPAN

FEI

FEI Number

3004262335

📍

Location

Mie-Gun, MIE

🇯🇵

Country

JAPAN
🏢

Address

3095-45, Oazanagai; Komono-Cho, Mie-Gun, MIE, Japan

Moderate Risk

FDA Import Risk Assessment

48.4
LowModerateHighCritical

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

Statistics

7
Total Refusals
3
Unique Violations
3/15/2022
Latest Refusal
10/27/2009
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
Refusal Volume
33.5×30%
Recency
9.1×20%
Frequency
5.7×10%
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

2956×

LISTERIA

The article is subject to refusal of admission pursuant to Section 801(a)(3), in that the article appears to contain Listeria monocytogenes, a poisonous and deleterious substance, which may render it injurious to health.

2561×

INCONSPICU

The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(f) of the FD&C Act in that any word, statement, or other information required by or under the authority of the FD&C Act to appear on the label or labeling is not prominently placed thereon with such conspicuousness (as compared with other words, statements, designs, or devices, in the labeling) and in such terms as to render it likely to be read and understood by the ordinary individual under customary terms of purchase and use (for example, label contains information in two or more languages but fails to repeat all required information in both languages in accordance with 21 CFR 101.15(c)(2), or label fails to include all required information in English in accordance with 21 CFR 101.15(c)(1), except in the case of articles distributed solely in the Commonwealth of Puerto Rico or in a Territory where the predominant language is one other than English)).

3061×

INSANITARY

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to have been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health.

Refusal History

DateProductViolationsDivision
3/15/2022
16YGD04FISH ROE, FISHERY PRODUCTS, N.E.C.
295LISTERIA
Division of West Coast Imports (DWCI)
12/3/2021
16YVT04FISH ROE, FISHERY PRODUCTS, N.E.C.
256INCONSPICU
295LISTERIA
Division of West Coast Imports (DWCI)
4/8/2015
16MGT03SQUID, OTHER AQUATIC SPECIES
295LISTERIA
Division of Northeast Imports (DNEI)
4/8/2015
16MGT03SQUID, OTHER AQUATIC SPECIES
295LISTERIA
Division of Northeast Imports (DNEI)
4/8/2015
16MGT03SQUID, OTHER AQUATIC SPECIES
295LISTERIA
Division of Northeast Imports (DNEI)
3/13/2013
16EGT02CLAMS
306INSANITARY
San Francisco District Office (SAN-DO)
10/27/2009
16YGD04FISH ROE, FISHERY PRODUCTS, N.E.C.
295LISTERIA
Chicago District Office (CHI-DO)

Frequently Asked Questions

What is Azuma Foods Co., Ltd.'s FDA import refusal history?

Azuma Foods Co., Ltd. (FEI: 3004262335) has 7 FDA import refusal record(s) in our database, spanning from 10/27/2009 to 3/15/2022.

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. Azuma Foods Co., Ltd.'s FEI number is 3004262335.

What types of violations has Azuma Foods Co., Ltd. received?

Azuma Foods 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 Azuma Foods Co., Ltd. come from?

All FDA import refusal data for Azuma Foods 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.