Sanada Co Ltd

⚠️ Moderate Risk

FEI: 3003560970 • Moriguchi, Osaka • JAPAN

FEI

FEI Number

3003560970

📍

Location

Moriguchi, Osaka

🇯🇵

Country

JAPAN

🏢

Address

2 Chome 21-13, Omiyadori, Moriguchi, Osaka, Japan

Moderate Risk

FDA Import Risk Assessment

37.7

LowModerateHighCritical

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

Statistics

Total Refusals

Unique Violations

6/19/2002

Latest Refusal

6/19/2002

Earliest Refusal

Score Breakdown

Violation Severity

55.8×40%

Refusal Volume

31.3×30%

Recency

0.0×20%

Frequency

60.0×10%

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

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).

3245×

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)).

4731×

LABELING

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

Refusal History

Date	Product	Violations	Division
6/19/2002	25EGT99MIXED VEGETABLES, N.E.C.	473LABELING 62NEEDS FCE	Los Angeles District Office (LOS-DO)
6/19/2002	25SGT99FUNGI PRODUCTS NOT MENTIONED ELSEWHERE, N.E.C.	324NO ENGLISH 62NEEDS FCE	Los Angeles District Office (LOS-DO)
6/19/2002	25EGT99MIXED VEGETABLES, N.E.C.	324NO ENGLISH 62NEEDS FCE	Los Angeles District Office (LOS-DO)
6/19/2002	25EGT99MIXED VEGETABLES, N.E.C.	324NO ENGLISH 62NEEDS FCE	Los Angeles District Office (LOS-DO)
6/19/2002	25EGT99MIXED VEGETABLES, N.E.C.	324NO ENGLISH 62NEEDS FCE	Los Angeles District Office (LOS-DO)
6/19/2002	25EGT99MIXED VEGETABLES, N.E.C.	324NO ENGLISH 62NEEDS FCE	Los Angeles District Office (LOS-DO)

Frequently Asked Questions

What is Sanada Co Ltd's FDA import refusal history?

Sanada Co Ltd (FEI: 3003560970) has 6 FDA import refusal record(s) in our database, spanning from 6/19/2002 to 6/19/2002.

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. Sanada Co Ltd's FEI number is 3003560970.

What types of violations has Sanada Co Ltd received?

Sanada 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 Sanada Co Ltd come from?

All FDA import refusal data for Sanada 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.