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Itoh trading Co.,Ltd.

⚠️ Moderate Risk

FEI: 3004253967 • Mizunami City, Gifu Pref • JAPAN

FEI

FEI Number

3004253967

📍

Location

Mizunami City, Gifu Pref

🇯🇵

Country

JAPAN
🏢

Address

891-1 Terakawado-Cho, , Mizunami City, Gifu Pref, Japan

Moderate Risk

FDA Import Risk Assessment

46.0
LowModerateHighCritical

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

Statistics

10
Total Refusals
7
Unique Violations
12/1/2023
Latest Refusal
4/19/2006
Earliest Refusal

Score Breakdown

Violation Severity
62.9×40%
Refusal Volume
38.6×30%
Recency
43.6×20%
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

3244×

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)).

93×

SALMONELLA

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

622×

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).

832×

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.

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.

2181×

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.

Refusal History

DateProductViolationsDivision
12/1/2023
16EYH05SCALLOPS
9SALMONELLA
Division of Northeast Imports (DNEI)
5/18/2011
16EGT05SCALLOPS
218LIST INGRE
473LABELING
9SALMONELLA
New York District Office (NYK-DO)
5/2/2011
04CGH05NOODLES, WHEAT AND SOY
324NO ENGLISH
New York District Office (NYK-DO)
5/2/2011
04CGH05NOODLES, WHEAT AND SOY
324NO ENGLISH
New York District Office (NYK-DO)
5/2/2011
04CGH05NOODLES, WHEAT AND SOY
324NO ENGLISH
New York District Office (NYK-DO)
5/2/2011
04CGH05NOODLES, WHEAT AND SOY
324NO ENGLISH
New York District Office (NYK-DO)
10/11/2007
16EGT05SCALLOPS
62NEEDS FCE
83NO PROCESS
Los Angeles District Office (LOS-DO)
10/11/2007
16EGT05SCALLOPS
62NEEDS FCE
83NO PROCESS
Los Angeles District Office (LOS-DO)
10/11/2007
16EGT05SCALLOPS
9SALMONELLA
Los Angeles District Office (LOS-DO)
4/19/2006
03FGT07RICE CRACKERS
64YELLOW #5
New York District Office (NYK-DO)

Frequently Asked Questions

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

Itoh trading Co.,Ltd. (FEI: 3004253967) has 10 FDA import refusal record(s) in our database, spanning from 4/19/2006 to 12/1/2023.

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. Itoh trading Co.,Ltd.'s FEI number is 3004253967.

What types of violations has Itoh trading Co.,Ltd. received?

Itoh trading Co.,Ltd. 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 Itoh trading Co.,Ltd. come from?

All FDA import refusal data for Itoh trading 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.