ImportRefusal LogoImportRefusal

Nikka Goods Co Ltd

⚠️ Moderate Risk

FEI: 3001923556 • Kobe, Hyogo • JAPAN

FEI

FEI Number

3001923556

📍

Location

Kobe, Hyogo

🇯🇵

Country

JAPAN
🏢

Address

4 Chome 3-33, Iwayakita-Machi; Nada, Kobe, Hyogo, Japan

Moderate Risk

FDA Import Risk Assessment

46.9
LowModerateHighCritical

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

Statistics

14
Total Refusals
2
Unique Violations
1/21/2010
Latest Refusal
5/3/2002
Earliest Refusal

Score Breakdown

Violation Severity
80.0×40%
Refusal Volume
43.6×30%
Recency
0.0×20%
Frequency
18.1×10%
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

8314×

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.

625×

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
1/21/2010
29YHF99SOFT DRINKS AND WATERS NOT MENTIONED ELSEWHERE, N.E.C.
62NEEDS FCE
83NO PROCESS
New York District Office (NYK-DO)
1/21/2010
29YHF99SOFT DRINKS AND WATERS NOT MENTIONED ELSEWHERE, N.E.C.
62NEEDS FCE
83NO PROCESS
New York District Office (NYK-DO)
11/20/2002
04CGT07NOODLES, INSTANT
62NEEDS FCE
83NO PROCESS
Los Angeles District Office (LOS-DO)
10/30/2002
04CGT07NOODLES, INSTANT
62NEEDS FCE
83NO PROCESS
Los Angeles District Office (LOS-DO)
10/30/2002
04CGT07NOODLES, INSTANT
62NEEDS FCE
83NO PROCESS
Los Angeles District Office (LOS-DO)
5/3/2002
37JCT99SAUCES, N.E.C.
83NO PROCESS
New York District Office (NYK-DO)
5/3/2002
37JCT99SAUCES, N.E.C.
83NO PROCESS
New York District Office (NYK-DO)
5/3/2002
37JCT99SAUCES, N.E.C.
83NO PROCESS
New York District Office (NYK-DO)
5/3/2002
37JCT99SAUCES, N.E.C.
83NO PROCESS
New York District Office (NYK-DO)
5/3/2002
37JCT99SAUCES, N.E.C.
83NO PROCESS
New York District Office (NYK-DO)
5/3/2002
37JCT99SAUCES, N.E.C.
83NO PROCESS
New York District Office (NYK-DO)
5/3/2002
37JCT99SAUCES, N.E.C.
83NO PROCESS
New York District Office (NYK-DO)
5/3/2002
37JCT99SAUCES, N.E.C.
83NO PROCESS
New York District Office (NYK-DO)
5/3/2002
37KCT99PASTES, N.E.C.
83NO PROCESS
New York District Office (NYK-DO)

Frequently Asked Questions

What is Nikka Goods Co Ltd's FDA import refusal history?

Nikka Goods Co Ltd (FEI: 3001923556) has 14 FDA import refusal record(s) in our database, spanning from 5/3/2002 to 1/21/2010.

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. Nikka Goods Co Ltd's FEI number is 3001923556.

What types of violations has Nikka Goods Co Ltd received?

Nikka Goods Co Ltd 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 Nikka Goods Co Ltd come from?

All FDA import refusal data for Nikka Goods 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.