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Mizuki International Corp

⚠️ Moderate Risk

FEI: 3004467485 • Kobe, Hyogo • JAPAN

FEI

FEI Number

3004467485

📍

Location

Kobe, Hyogo

🇯🇵

Country

JAPAN
🏢

Address

Boeki Bldg 123-1, Higashi-Machi; Chuo, Kobe, Hyogo, Japan

Moderate Risk

FDA Import Risk Assessment

36.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
3/6/2006
Latest Refusal
3/6/2006
Earliest Refusal

Score Breakdown

Violation Severity
80.0×40%
Refusal Volume
11.2×30%
Recency
0.0×20%
Frequency
10.0×10%
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

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
3/6/2006
29YFF99SOFT DRINKS AND WATERS NOT MENTIONED ELSEWHERE, N.E.C.
83NO PROCESS
New York District Office (NYK-DO)

Frequently Asked Questions

What is Mizuki International Corp's FDA import refusal history?

Mizuki International Corp (FEI: 3004467485) has 1 FDA import refusal record(s) in our database, spanning from 3/6/2006 to 3/6/2006.

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. Mizuki International Corp's FEI number is 3004467485.

What types of violations has Mizuki International Corp received?

Mizuki International Corp 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 Mizuki International Corp come from?

All FDA import refusal data for Mizuki International Corp 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.