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YAMANO

⚠️ Moderate Risk

FEI: 3021626100 • Kumage-Gun, Kagoshima • JAPAN

FEI

FEI Number

3021626100

📍

Location

Kumage-Gun, Kagoshima

🇯🇵

Country

JAPAN
🏢

Address

2402-171, Anbo; Yakushima-Cho, Kumage-Gun, Kagoshima, Japan

Moderate Risk

FDA Import Risk Assessment

30.8
LowModerateHighCritical

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

Statistics

1
Total Refusals
2
Unique Violations
9/1/2023
Latest Refusal
9/1/2023
Earliest Refusal

Score Breakdown

Violation Severity
40.0×40%
Refusal Volume
11.2×30%
Recency
52.2×20%
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

23001×

DIETARYLBL

The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it is a dietary supplement that appears to be misbranded within the meaning of Section 403(s)(2)(B) of the FD&C Act in that the label or labeling fails to identify the product by using the term "dietary supplement", which term may be modified with the name of such an ingredient.

4821×

NUTRIT LBL

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded in that the label or labeling fails to bear the required nutrition information.

Refusal History

DateProductViolationsDivision
9/1/2023
54YBY99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.
2300DIETARYLBL
482NUTRIT LBL
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is YAMANO's FDA import refusal history?

YAMANO (FEI: 3021626100) has 1 FDA import refusal record(s) in our database, spanning from 9/1/2023 to 9/1/2023.

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. YAMANO's FEI number is 3021626100.

What types of violations has YAMANO received?

YAMANO has been cited for 2 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 YAMANO come from?

All FDA import refusal data for YAMANO 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.