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Makoto Shokai Co., Ltd.

⚠️ Moderate Risk

FEI: 3004799737 • Naka, Osaka • JAPAN

FEI

FEI Number

3004799737

📍

Location

Naka, Osaka

🇯🇵

Country

JAPAN
🏢

Address

2 14-1, Honjo; Higashi-Kuosaka, Naka, Osaka, Japan

Moderate Risk

FDA Import Risk Assessment

41.5
LowModerateHighCritical

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

Statistics

2
Total Refusals
1
Unique Violations
8/1/2019
Latest Refusal
6/29/2010
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
Refusal Volume
17.7×30%
Recency
0.0×20%
Frequency
2.2×10%
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

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).

Refusal History

DateProductViolationsDivision
8/1/2019
33EGT99HARD CANDY WITHOUT NUTS AND FRUIT, N.E.C. (WITHOUT CHOCOLATE)
11UNSAFE COL
Division of Northern Border Imports (DNBI)
6/29/2010
33LGT07JELLIED CANDY, SOFT (JELLY BEANS, GUM DROPS, ETC.), WITHOUT NUTS AND FRUIT (WITHOUT CHOCOLATE)
11UNSAFE COL
New York District Office (NYK-DO)

Frequently Asked Questions

What is Makoto Shokai Co., Ltd.'s FDA import refusal history?

Makoto Shokai Co., Ltd. (FEI: 3004799737) has 2 FDA import refusal record(s) in our database, spanning from 6/29/2010 to 8/1/2019.

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. Makoto Shokai Co., Ltd.'s FEI number is 3004799737.

What types of violations has Makoto Shokai Co., Ltd. received?

Makoto Shokai Co., Ltd. has been cited for 1 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 Makoto Shokai Co., Ltd. come from?

All FDA import refusal data for Makoto Shokai 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.