ImportRefusal LogoImportRefusal

Inoue Shokuhin Co., Ltd. (Reizoko)

⚠️ High Risk

FEI: 3010182303 • Kobe, Hyogo • JAPAN

FEI

FEI Number

3010182303

📍

Location

Kobe, Hyogo

🇯🇵

Country

JAPAN
🏢

Address

1-13, Tsukiji-Cho; Hyogo, Kobe, Hyogo, Japan

High Risk

FDA Import Risk Assessment

59.9
LowModerateHighCritical

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

Statistics

18
Total Refusals
8
Unique Violations
8/2/2024
Latest Refusal
9/12/2017
Earliest Refusal

Score Breakdown

Violation Severity
72.2×40%
Refusal Volume
47.4×30%
Recency
70.8×20%
Frequency
26.1×10%
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

626×

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).

115×

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).

835×

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.

2744×

COLOR LBLG

The article appears to contain an artificial coloring and it fails to bear labeling stating that fact.

3083×

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.

4732×

LABELING

The article appears in violation of FPLA because of its placement, form and/or contents statement.

34001×

PB-FOOD

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to contain a poisonous or deleterious substance, lead, 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)).

Refusal History

DateProductViolationsDivision
8/2/2024
25PGT11ENOKITAKE MUSHROOMS, WHOLE (BUTTON) (FUNGI)
256INCONSPICU
Division of West Coast Imports (DWCI)
11/21/2023
25JGT24GINGER ROOT (ROOT & TUBER VEGETABLE)
11UNSAFE COL
Division of West Coast Imports (DWCI)
3/24/2022
21GGT14PLUM (PIT FRUIT)
3400PB-FOOD
Division of West Coast Imports (DWCI)
4/28/2020
33MHT05GEL CUPS CANDY
11UNSAFE COL
274COLOR LBLG
Division of West Coast Imports (DWCI)
4/28/2020
33MHT05GEL CUPS CANDY
11UNSAFE COL
274COLOR LBLG
Division of West Coast Imports (DWCI)
4/28/2020
33MHT05GEL CUPS CANDY
11UNSAFE COL
274COLOR LBLG
Division of West Coast Imports (DWCI)
5/14/2019
33MGT05GEL CUPS CANDY
11UNSAFE COL
274COLOR LBLG
Division of West Coast Imports (DWCI)
5/3/2019
16YGT17SAUCE, SEAFOOD (N.E.C.), FISHERY PRODUCTS, N.E.C.
62NEEDS FCE
83NO PROCESS
Division of West Coast Imports (DWCI)
5/3/2019
25JGI24GINGER ROOT (ROOT & TUBER VEGETABLE)
62NEEDS FCE
83NO PROCESS
Division of West Coast Imports (DWCI)
5/3/2019
25JCI21GARLIC BULB (ROOT & TUBER VEGETABLE)
62NEEDS FCE
83NO PROCESS
Division of West Coast Imports (DWCI)
11/14/2018
16AGH01ANCHOVY
308MFR INSAN
Division of West Coast Imports (DWCI)
11/14/2018
16AGH01ANCHOVY
308MFR INSAN
Division of West Coast Imports (DWCI)
11/14/2018
16AGH01ANCHOVY
308MFR INSAN
Division of West Coast Imports (DWCI)
1/17/2018
16YGT17SAUCE, SEAFOOD (N.E.C.), FISHERY PRODUCTS, N.E.C.
473LABELING
Division of West Coast Imports (DWCI)
1/17/2018
16YGT17SAUCE, SEAFOOD (N.E.C.), FISHERY PRODUCTS, N.E.C.
473LABELING
Division of West Coast Imports (DWCI)
12/20/2017
54YCL99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.
62NEEDS FCE
83NO PROCESS
Division of West Coast Imports (DWCI)
9/12/2017
24AGT19ADZUKI BEANS
62NEEDS FCE
83NO PROCESS
Division of West Coast Imports (DWCI)
9/12/2017
25ECT99MIXED VEGETABLES, N.E.C.
62NEEDS FCE
Division of West Coast Imports (DWCI)

Frequently Asked Questions

What is Inoue Shokuhin Co., Ltd. (Reizoko)'s FDA import refusal history?

Inoue Shokuhin Co., Ltd. (Reizoko) (FEI: 3010182303) has 18 FDA import refusal record(s) in our database, spanning from 9/12/2017 to 8/2/2024.

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. Inoue Shokuhin Co., Ltd. (Reizoko)'s FEI number is 3010182303.

What types of violations has Inoue Shokuhin Co., Ltd. (Reizoko) received?

Inoue Shokuhin Co., Ltd. (Reizoko) has been cited for 8 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 Inoue Shokuhin Co., Ltd. (Reizoko) come from?

All FDA import refusal data for Inoue Shokuhin Co., Ltd. (Reizoko) 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.