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Wooke Co., Ltd.

⚠️ Moderate Risk

FEI: 3010192136 • Shimoniikawa-Gun, Toyama • JAPAN

FEI

FEI Number

3010192136

📍

Location

Shimoniikawa-Gun, Toyama

🇯🇵

Country

JAPAN
🏢

Address

232-5, Shimoiino; Nyuzen-Machi, Shimoniikawa-Gun, Toyama, Japan

Moderate Risk

FDA Import Risk Assessment

41.7
LowModerateHighCritical

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

Statistics

3
Total Refusals
1
Unique Violations
8/9/2013
Latest Refusal
8/9/2013
Earliest Refusal

Score Breakdown

Violation Severity
80.0×40%
Refusal Volume
22.3×30%
Recency
0.0×20%
Frequency
30.0×10%
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

623×

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
8/9/2013
02DGT02RICE, PLAIN (WHITE OR POLISHED) PROCESSED (PACKAGED)
62NEEDS FCE
Los Angeles District Office (LOS-DO)
8/9/2013
02DGT02RICE, PLAIN (WHITE OR POLISHED) PROCESSED (PACKAGED)
62NEEDS FCE
Los Angeles District Office (LOS-DO)
8/9/2013
02DGT02RICE, PLAIN (WHITE OR POLISHED) PROCESSED (PACKAGED)
62NEEDS FCE
Los Angeles District Office (LOS-DO)

Frequently Asked Questions

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

Wooke Co., Ltd. (FEI: 3010192136) has 3 FDA import refusal record(s) in our database, spanning from 8/9/2013 to 8/9/2013.

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. Wooke Co., Ltd.'s FEI number is 3010192136.

What types of violations has Wooke Co., Ltd. received?

Wooke 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 Wooke Co., Ltd. come from?

All FDA import refusal data for Wooke 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.