ImportRefusal LogoImportRefusal

NIKKOH CONFECTIONERY CO.,LTD.

⚠️ Moderate Risk

FEI: 3004347100 • Kakamigahara, Gifu • JAPAN

FEI

FEI Number

3004347100

📍

Location

Kakamigahara, Gifu

🇯🇵

Country

JAPAN
🏢

Address

41 Yamazaki-Cho, Naka, Kakamigahara, Gifu, 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
2/12/2018
Latest Refusal
2/12/2018
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
2/12/2018
07YGT99SNACK FOODS NOT ELSEWHERE MENTIONED, N.E.C.
83NO PROCESS
Division of West Coast Imports (DWCI)

Frequently Asked Questions

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

NIKKOH CONFECTIONERY CO.,LTD. (FEI: 3004347100) has 1 FDA import refusal record(s) in our database, spanning from 2/12/2018 to 2/12/2018.

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. NIKKOH CONFECTIONERY CO.,LTD.'s FEI number is 3004347100.

What types of violations has NIKKOH CONFECTIONERY CO.,LTD. received?

NIKKOH CONFECTIONERY 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 NIKKOH CONFECTIONERY CO.,LTD. come from?

All FDA import refusal data for NIKKOH CONFECTIONERY 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.