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TOHO SEIKA Co., Ltd.

⚠️ Moderate Risk

FEI: 3009883036 • Toyohashi, Aichi • JAPAN

FEI

FEI Number

3009883036

📍

Location

Toyohashi, Aichi

🇯🇵

Country

JAPAN
🏢

Address

1 Chome 156, Kasuga-Cho, Toyohashi, Aichi, Japan

Moderate Risk

FDA Import Risk Assessment

42.7
LowModerateHighCritical

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

Statistics

5
Total Refusals
3
Unique Violations
3/13/2017
Latest Refusal
7/31/2013
Earliest Refusal

Score Breakdown

Violation Severity
81.7×40%
Refusal Volume
28.8×30%
Recency
0.0×20%
Frequency
13.8×10%
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

624×

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).

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).

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.

Refusal History

DateProductViolationsDivision
3/13/2017
37BGT99MULTIPLE FOOD SPECIALITIES, SIDE DISHES AND DESSERTS, N.E.C.
62NEEDS FCE
83NO PROCESS
Los Angeles District Office (LOS-DO)
1/22/2015
37BGT99MULTIPLE FOOD SPECIALITIES, SIDE DISHES AND DESSERTS, N.E.C.
62NEEDS FCE
Los Angeles District Office (LOS-DO)
8/27/2014
37BGT99MULTIPLE FOOD SPECIALITIES, SIDE DISHES AND DESSERTS, N.E.C.
62NEEDS FCE
Los Angeles District Office (LOS-DO)
8/27/2014
37BGT99MULTIPLE FOOD SPECIALITIES, SIDE DISHES AND DESSERTS, N.E.C.
62NEEDS FCE
Los Angeles District Office (LOS-DO)
7/31/2013
37BGT99MULTIPLE FOOD SPECIALITIES, SIDE DISHES AND DESSERTS, N.E.C.
11UNSAFE COL
Los Angeles District Office (LOS-DO)

Frequently Asked Questions

What is TOHO SEIKA Co., Ltd.'s FDA import refusal history?

TOHO SEIKA Co., Ltd. (FEI: 3009883036) has 5 FDA import refusal record(s) in our database, spanning from 7/31/2013 to 3/13/2017.

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. TOHO SEIKA Co., Ltd.'s FEI number is 3009883036.

What types of violations has TOHO SEIKA Co., Ltd. received?

TOHO SEIKA 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 TOHO SEIKA Co., Ltd. come from?

All FDA import refusal data for TOHO SEIKA 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.