Sanko Seika Co., Ltd. Niizaki Factory

⚠️ Moderate Risk

FEI: 1000193554 • Niigata, Niigata • JAPAN

FEI

FEI Number

1000193554

📍

Location

Niigata, Niigata

🇯🇵

Country

JAPAN

🏢

Address

3 Saiwaiseika ( Kabu ), 2 Chome 6-1; Niizaki; Kita, Niigata, Niigata, Japan

Moderate Risk

FDA Import Risk Assessment

35.8

LowModerateHighCritical

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

Statistics

Total Refusals

Unique Violations

11/19/2013

Latest Refusal

11/3/2003

Earliest Refusal

Score Breakdown

Violation Severity

66.7×40%

Refusal Volume

28.8×30%

Recency

0.0×20%

Frequency

5.0×10%

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

2182×

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.

2382×

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.

111×

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).

2601×

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.

Refusal History

Date	Product	Violations	Division
11/19/2013	03FGT07RICE CRACKERS	238UNSAFE ADD	Los Angeles District Office (LOS-DO)
11/19/2013	03FGT07RICE CRACKERS	238UNSAFE ADD	Los Angeles District Office (LOS-DO)
7/31/2013	03FGT07RICE CRACKERS	11UNSAFE COL	Los Angeles District Office (LOS-DO)
2/15/2007	03FGN07RICE CRACKERS	218LIST INGRE 260FALSE	Los Angeles District Office (LOS-DO)
11/3/2003	03FGT07RICE CRACKERS	218LIST INGRE	Los Angeles District Office (LOS-DO)

Frequently Asked Questions

What is Sanko Seika Co., Ltd. Niizaki Factory's FDA import refusal history?

Sanko Seika Co., Ltd. Niizaki Factory (FEI: 1000193554) has 5 FDA import refusal record(s) in our database, spanning from 11/3/2003 to 11/19/2013.

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. Sanko Seika Co., Ltd. Niizaki Factory's FEI number is 1000193554.

What types of violations has Sanko Seika Co., Ltd. Niizaki Factory received?

Sanko Seika Co., Ltd. Niizaki Factory 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 Sanko Seika Co., Ltd. Niizaki Factory come from?

All FDA import refusal data for Sanko Seika Co., Ltd. Niizaki Factory 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.