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NIKKO YAKUHIN KOGYO CO.,LTD.

⚠️ Moderate Risk

FEI: 3007781235 • Nagoya, Aichi • JAPAN

FEI

FEI Number

3007781235

📍

Location

Nagoya, Aichi

🇯🇵

Country

JAPAN
🏢

Address

2 Chome, Hara; Tenpaku, Nagoya, Aichi, Japan

Moderate Risk

FDA Import Risk Assessment

33.7
LowModerateHighCritical

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

Statistics

3
Total Refusals
1
Unique Violations
9/1/2017
Latest Refusal
7/3/2017
Earliest Refusal

Score Breakdown

Violation Severity
60.0×40%
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

35603×

SUPPL GMP

The article appears to be a dietary supplement and it has been prepared, packed, or held under conditions that do not meet current good manufacturing practice regulations.

Refusal History

DateProductViolationsDivision
9/1/2017
54YCL99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.
3560SUPPL GMP
Division of Southeast Imports (DSEI)
7/3/2017
54YCY99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.
3560SUPPL GMP
Division of West Coast Imports (DWCI)
7/3/2017
54YCY99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.
3560SUPPL GMP
Division of West Coast Imports (DWCI)

Frequently Asked Questions

What is NIKKO YAKUHIN KOGYO CO.,LTD.'s FDA import refusal history?

NIKKO YAKUHIN KOGYO CO.,LTD. (FEI: 3007781235) has 3 FDA import refusal record(s) in our database, spanning from 7/3/2017 to 9/1/2017.

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. NIKKO YAKUHIN KOGYO CO.,LTD.'s FEI number is 3007781235.

What types of violations has NIKKO YAKUHIN KOGYO CO.,LTD. received?

NIKKO YAKUHIN KOGYO 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 NIKKO YAKUHIN KOGYO CO.,LTD. come from?

All FDA import refusal data for NIKKO YAKUHIN KOGYO 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.