ImportRefusal LogoImportRefusal

KURODA SHOKUHIN

⚠️ Moderate Risk

FEI: 3004299309 • Kobe, Hyogo • JAPAN

FEI

FEI Number

3004299309

📍

Location

Kobe, Hyogo

🇯🇵

Country

JAPAN
🏢

Address

1 Chome 5-11, Shichinomiya-Cho; Hyogo, Kobe, Hyogo, Japan

Moderate Risk

FDA Import Risk Assessment

38.1
LowModerateHighCritical

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

Statistics

7
Total Refusals
7
Unique Violations
7/20/2018
Latest Refusal
1/4/2002
Earliest Refusal

Score Breakdown

Violation Severity
69.1×40%
Refusal Volume
33.5×30%
Recency
0.0×20%
Frequency
4.2×10%
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

2383×

UNSAFE ADD

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to bear or contain an unsafe food additive within the meaning of section 409.

833×

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.

3281×

USUAL NAME

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(i)(1) of the FD&C Act in that the label fails to bear the common or usual name of the food, if any there be.

621×

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).

641×

YELLOW #5

The food appears to bear or contain the color additive FD & C Yellow No. 5, which is not declared on the label per 21 CFR 74.705(a)(c) under section 721.

4731×

LABELING

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

3241×

NO ENGLISH

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
7/20/2018
25JGP26CHINESE RADISH (DAIKON) (ROOT & TUBER VEGETABLE)
238UNSAFE ADD
Division of West Coast Imports (DWCI)
4/17/2018
25JGP26CHINESE RADISH (DAIKON) (ROOT & TUBER VEGETABLE)
238UNSAFE ADD
Division of West Coast Imports (DWCI)
9/12/2017
25EGT99MIXED VEGETABLES, N.E.C.
62NEEDS FCE
83NO PROCESS
Division of West Coast Imports (DWCI)
7/26/2011
24FGT99FRUITS USED AS VEGETABLES, N.E.C.
238UNSAFE ADD
324NO ENGLISH
328USUAL NAME
473LABELING
New York District Office (NYK-DO)
12/31/2002
24FGT20CUCUMBERS (FRUIT USED AS VEGETABLE)
83NO PROCESS
Los Angeles District Office (LOS-DO)
12/31/2002
24FGT20CUCUMBERS (FRUIT USED AS VEGETABLE)
83NO PROCESS
Los Angeles District Office (LOS-DO)
1/4/2002
25NGT07RADISH, WITH SAUCE
64YELLOW #5
Atlanta District Office (ATL-DO)

Frequently Asked Questions

What is KURODA SHOKUHIN's FDA import refusal history?

KURODA SHOKUHIN (FEI: 3004299309) has 7 FDA import refusal record(s) in our database, spanning from 1/4/2002 to 7/20/2018.

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. KURODA SHOKUHIN's FEI number is 3004299309.

What types of violations has KURODA SHOKUHIN received?

KURODA SHOKUHIN has been cited for 7 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 KURODA SHOKUHIN come from?

All FDA import refusal data for KURODA SHOKUHIN 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.