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Shoei co.,Ltd

⚠️ Moderate Risk

FEI: 3011093003 • Adachi, Tokyo • JAPAN

FEI

FEI Number

3011093003

📍

Location

Adachi, Tokyo

🇯🇵

Country

JAPAN
🏢

Address

46-4, Senjukawara-Cho, Adachi, Tokyo, Japan

Moderate Risk

FDA Import Risk Assessment

40.4
LowModerateHighCritical

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

Statistics

20
Total Refusals
8
Unique Violations
10/19/2010
Latest Refusal
9/30/2008
Earliest Refusal

Score Breakdown

Violation Severity
40.0×40%
Refusal Volume
49.0×30%
Recency
0.0×20%
Frequency
97.5×10%
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

21818×

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.

48214×

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.

32112×

LACKS N/C

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(e)(2) of the FD&C Act in that the food is in package form and the label fails to bear an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count in accordance with Section 403(e)(2) of the FD&C Act.

3285×

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.

642×

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.

2562×

INCONSPICU

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)).

112×

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).

2761×

PRESRV LBL

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to contain a chemical preservative and it fails to bear labeling stating that fact including its function.

Refusal History

DateProductViolationsDivision
10/19/2010
03YGE12RICE CAKES
11UNSAFE COL
321LACKS N/C
482NUTRIT LBL
64YELLOW #5
San Francisco District Office (SAN-DO)
10/19/2010
03YGE12RICE CAKES
11UNSAFE COL
321LACKS N/C
482NUTRIT LBL
64YELLOW #5
San Francisco District Office (SAN-DO)
2/24/2010
03YGE12RICE CAKES
218LIST INGRE
San Francisco District Office (SAN-DO)
2/24/2010
03YGE12RICE CAKES
218LIST INGRE
San Francisco District Office (SAN-DO)
2/24/2010
03YGE12RICE CAKES
218LIST INGRE
San Francisco District Office (SAN-DO)
2/24/2010
34EGE04CHOCOLATE COVERED CANDY PIECES, WITH FRUIT AND FRUIT PRODUCTS
218LIST INGRE
San Francisco District Office (SAN-DO)
2/24/2010
03YGE12RICE CAKES
218LIST INGRE
San Francisco District Office (SAN-DO)
2/24/2010
03YGE12RICE CAKES
218LIST INGRE
San Francisco District Office (SAN-DO)
1/23/2009
34EGE04CHOCOLATE COVERED CANDY PIECES, WITH FRUIT AND FRUIT PRODUCTS
218LIST INGRE
256INCONSPICU
482NUTRIT LBL
San Francisco District Office (SAN-DO)
1/23/2009
34FGE04CHOCOLATE COVERED CANDY PIECES, WITHOUT NUTS AND FRUIT
218LIST INGRE
256INCONSPICU
482NUTRIT LBL
San Francisco District Office (SAN-DO)
12/1/2008
03YGE12RICE CAKES
218LIST INGRE
321LACKS N/C
482NUTRIT LBL
San Francisco District Office (SAN-DO)
12/1/2008
03YGE12RICE CAKES
218LIST INGRE
321LACKS N/C
482NUTRIT LBL
San Francisco District Office (SAN-DO)
12/1/2008
03YGE12RICE CAKES
218LIST INGRE
321LACKS N/C
328USUAL NAME
482NUTRIT LBL
San Francisco District Office (SAN-DO)
12/1/2008
34CGE04CHOCOLATE COVERED CANDY PIECES, WITH NUTS OR NUT PRODUCTS (NOT COCONUT)
218LIST INGRE
321LACKS N/C
328USUAL NAME
482NUTRIT LBL
San Francisco District Office (SAN-DO)
12/1/2008
03YGE12RICE CAKES
218LIST INGRE
321LACKS N/C
328USUAL NAME
482NUTRIT LBL
San Francisco District Office (SAN-DO)
12/1/2008
03YGE12RICE CAKES
218LIST INGRE
321LACKS N/C
328USUAL NAME
482NUTRIT LBL
San Francisco District Office (SAN-DO)
12/1/2008
34EGE04CHOCOLATE COVERED CANDY PIECES, WITH FRUIT AND FRUIT PRODUCTS
218LIST INGRE
321LACKS N/C
328USUAL NAME
482NUTRIT LBL
San Francisco District Office (SAN-DO)
9/30/2008
03YGE12RICE CAKES
218LIST INGRE
321LACKS N/C
482NUTRIT LBL
San Francisco District Office (SAN-DO)
9/30/2008
03YGE12RICE CAKES
218LIST INGRE
321LACKS N/C
482NUTRIT LBL
San Francisco District Office (SAN-DO)
9/30/2008
34CGE04CHOCOLATE COVERED CANDY PIECES, WITH NUTS OR NUT PRODUCTS (NOT COCONUT)
218LIST INGRE
276PRESRV LBL
321LACKS N/C
482NUTRIT LBL
San Francisco District Office (SAN-DO)

Frequently Asked Questions

What is Shoei co.,Ltd's FDA import refusal history?

Shoei co.,Ltd (FEI: 3011093003) has 20 FDA import refusal record(s) in our database, spanning from 9/30/2008 to 10/19/2010.

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. Shoei co.,Ltd's FEI number is 3011093003.

What types of violations has Shoei co.,Ltd received?

Shoei co.,Ltd has been cited for 8 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 Shoei co.,Ltd come from?

All FDA import refusal data for Shoei 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.