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Onoguchi Co., Ltd.

⚠️ Moderate Risk

FEI: 1000194871 • Tochigi, Tochigi • JAPAN

FEI

FEI Number

1000194871

📍

Location

Tochigi, Tochigi

🇯🇵

Country

JAPAN
🏢

Address

24-24 2-Chome Shirouchi-Cho, , Tochigi, Tochigi, Japan

Moderate Risk

FDA Import Risk Assessment

34.2
LowModerateHighCritical

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

Statistics

10
Total Refusals
4
Unique Violations
7/30/2021
Latest Refusal
5/24/2005
Earliest Refusal

Score Breakdown

Violation Severity
55.0×40%
Refusal Volume
38.6×30%
Recency
0.0×20%
Frequency
6.2×10%
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

20406×

SULFITELBL

The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded because 1) it appears to contain sulfites but the label fails to declare the presence of sulfites, a fact material to sulfite-sensitive individuals who must avoid the ingredient due to potential health consequences from its consumption, and 2) it appears the food is fabricated from two or more ingredients and the label does not list the common or usual name of each ingredient.

2184×

LIST INGRE

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)(2) of the FD&C Act in that it is fabricated from two or more ingredients and the label fails to bear the common or usual name of each such ingredient and/or the article purports to be a beverage containing vegetable or fruit juice, but does not bear a statement with appropriate prominence on the information panel of the total percentage of such fruit or vegetable juice contained in the food.

2603×

FALSE

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(a)(1 ) of the FD&C Act in that the labeling is false or misleading in any particular.

4821×

NUTRIT LBL

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded in that the label or labeling fails to bear the required nutrition information.

Refusal History

DateProductViolationsDivision
7/30/2021
24HGH09GOURD, DRIED OR PASTE
2040SULFITELBL
218LIST INGRE
Division of West Coast Imports (DWCI)
12/1/2020
24HGH09GOURD, DRIED OR PASTE
2040SULFITELBL
Division of West Coast Imports (DWCI)
11/18/2020
24HGH09GOURD, DRIED OR PASTE
2040SULFITELBL
Division of West Coast Imports (DWCI)
5/20/2020
24HGH09GOURD, DRIED OR PASTE
2040SULFITELBL
Division of West Coast Imports (DWCI)
3/15/2011
24HGH09GOURD, DRIED OR PASTE
2040SULFITELBL
New York District Office (NYK-DO)
5/6/2010
24HGH09GOURD, DRIED OR PASTE
218LIST INGRE
260FALSE
Chicago District Office (CHI-DO)
5/6/2010
24HGH09GOURD, DRIED OR PASTE
218LIST INGRE
260FALSE
Chicago District Office (CHI-DO)
5/6/2010
24HGH09GOURD, DRIED OR PASTE
218LIST INGRE
260FALSE
Chicago District Office (CHI-DO)
4/28/2006
24HGH09GOURD, DRIED OR PASTE
2040SULFITELBL
New York District Office (NYK-DO)
5/24/2005
24HGT09GOURD, DRIED OR PASTE
482NUTRIT LBL
New York District Office (NYK-DO)

Frequently Asked Questions

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

Onoguchi Co., Ltd. (FEI: 1000194871) has 10 FDA import refusal record(s) in our database, spanning from 5/24/2005 to 7/30/2021.

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. Onoguchi Co., Ltd.'s FEI number is 1000194871.

What types of violations has Onoguchi Co., Ltd. received?

Onoguchi Co., Ltd. has been cited for 4 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 Onoguchi Co., Ltd. come from?

All FDA import refusal data for Onoguchi 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.