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Shinshin Co. Ltd.

⚠️ Moderate Risk

FEI: 1000134905 • Tokyo • JAPAN

FEI

FEI Number

1000134905

📍

Location

Tokyo

🇯🇵

Country

JAPAN
🏢

Address

3-38 Kanda Sakunai Cyochiyoda-Ku, , Tokyo, , Japan

Moderate Risk

FDA Import Risk Assessment

40.2
LowModerateHighCritical

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

Statistics

11
Total Refusals
7
Unique Violations
1/17/2018
Latest Refusal
2/6/2004
Earliest Refusal

Score Breakdown

Violation Severity
68.5×40%
Refusal Volume
40.0×30%
Recency
0.0×20%
Frequency
7.9×10%
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

113×

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).

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.

2742×

COLOR LBLG

The article appears to contain an artificial coloring and it fails to bear labeling stating that fact.

4732×

LABELING

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

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.

831×

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.

621×

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).

Refusal History

DateProductViolationsDivision
1/17/2018
25EGP99MIXED VEGETABLES, N.E.C.
473LABELING
Division of West Coast Imports (DWCI)
1/17/2018
25EGP99MIXED VEGETABLES, N.E.C.
473LABELING
Division of West Coast Imports (DWCI)
2/26/2013
24TEE03BAMBOO SHOOTS (LEAF & STEM VEGETABLE)
64YELLOW #5
San Francisco District Office (SAN-DO)
5/11/2012
25JGP07RADISH (ROOT & TUBER VEGETABLE)
11UNSAFE COL
San Francisco District Office (SAN-DO)
5/11/2012
25JGP07RADISH (ROOT & TUBER VEGETABLE)
11UNSAFE COL
San Francisco District Office (SAN-DO)
1/4/2012
24TGT03BAMBOO SHOOTS (LEAF & STEM VEGETABLE)
274COLOR LBLG
San Francisco District Office (SAN-DO)
1/3/2012
24TGT03BAMBOO SHOOTS (LEAF & STEM VEGETABLE)
64YELLOW #5
San Francisco District Office (SAN-DO)
10/16/2008
25JGP21GARLIC BULB (ROOT & TUBER VEGETABLE)
274COLOR LBLG
San Francisco District Office (SAN-DO)
12/4/2006
24KGT20CUCUMBERS, WITH SAUCE
62NEEDS FCE
83NO PROCESS
Los Angeles District Office (LOS-DO)
8/19/2005
25JGD07RADISH (ROOT & TUBER VEGETABLE)
11UNSAFE COL
238UNSAFE ADD
New York District Office (NYK-DO)
2/6/2004
25JGT07RADISH (ROOT & TUBER VEGETABLE)
238UNSAFE ADD
Baltimore District Office (BLT-DO)

Frequently Asked Questions

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

Shinshin Co. Ltd. (FEI: 1000134905) has 11 FDA import refusal record(s) in our database, spanning from 2/6/2004 to 1/17/2018.

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. Shinshin Co. Ltd.'s FEI number is 1000134905.

What types of violations has Shinshin Co. Ltd. received?

Shinshin 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 Shinshin Co. Ltd. come from?

All FDA import refusal data for Shinshin 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.