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OTAKE CO.,LTD.

⚠️ Moderate Risk

FEI: 3004549515 • Shizuoka, Shizuoka • JAPAN

FEI

FEI Number

3004549515

📍

Location

Shizuoka, Shizuoka

🇯🇵

Country

JAPAN
🏢

Address

Shibukawa; Shimizu; Shibukawa; Shimizu; 3 Chome 10-1; Shibukawa; Shimizu; Shibukawa; Shimizu, , Shizuoka, Shizuoka, Japan

Moderate Risk

FDA Import Risk Assessment

31.3
LowModerateHighCritical

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

Statistics

2
Total Refusals
1
Unique Violations
4/7/2016
Latest Refusal
1/27/2016
Earliest Refusal

Score Breakdown

Violation Severity
60.0×40%
Refusal Volume
17.7×30%
Recency
0.0×20%
Frequency
20.0×10%
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

© ImportRefusal.com Original Analysis

Violation Summary

3092×

FORBIDDEN

The article is subject to refusal of admission pursuant to Section 801(a)(2) in that it appears to be forbidden or restricted in sale in the country in which it was produced or from which it was exported.

Refusal History

DateProductViolationsDivision
4/7/2016
25PGH99MUSHROOMS AND OTHER FUNGI PRODUCTS, WHOLE (BUTTON), N.E.C.
309FORBIDDEN
Division of Northeast Imports (DNEI)
1/27/2016
25PGH99MUSHROOMS AND OTHER FUNGI PRODUCTS, WHOLE (BUTTON), N.E.C.
309FORBIDDEN
Division of Northeast Imports (DNEI)

Frequently Asked Questions

What is OTAKE CO.,LTD.'s FDA import refusal history?

OTAKE CO.,LTD. (FEI: 3004549515) has 2 FDA import refusal record(s) in our database, spanning from 1/27/2016 to 4/7/2016.

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. OTAKE CO.,LTD.'s FEI number is 3004549515.

What types of violations has OTAKE CO.,LTD. received?

OTAKE 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 OTAKE CO.,LTD. come from?

All FDA import refusal data for OTAKE 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.