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NIHONSAKARI CO., LTD.

⚠️ Moderate Risk

FEI: 3008436343 • Nishinomiya, Hyogo • JAPAN

FEI

FEI Number

3008436343

📍

Location

Nishinomiya, Hyogo

🇯🇵

Country

JAPAN
🏢

Address

Nihonsakari (Kabu); 4-57; Yogai-Cho, , Nishinomiya, Hyogo, Japan

Moderate Risk

FDA Import Risk Assessment

25.7
LowModerateHighCritical

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

Statistics

3
Total Refusals
1
Unique Violations
1/14/2015
Latest Refusal
12/18/2014
Earliest Refusal

Score Breakdown

Violation Severity
40.0×40%
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

4713×

CSTIC LBLG

The labeling appears to fail to comply with cosmetic labeling requirements of Section 602(a), and/or (b), and/or (c), and as identified by 21 C.F.R. Part 701.

Refusal History

DateProductViolationsDivision
1/14/2015
53EY07TONICS, DRESSINGS, AND OTHER HAIR GROOMING AIDS (HAIR PREPARATIONS, NON-COLORING)
471CSTIC LBLG
Cincinnati District Office (CIN-DO)
1/14/2015
53LY99OTHER SKIN CARE PREPARATIONS, N.E.C.
471CSTIC LBLG
Cincinnati District Office (CIN-DO)
12/18/2014
53EY06SHAMPOOS (HAIR PREPARATIONS, NON-COLORING)
471CSTIC LBLG
Cincinnati District Office (CIN-DO)

Frequently Asked Questions

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

NIHONSAKARI CO., LTD. (FEI: 3008436343) has 3 FDA import refusal record(s) in our database, spanning from 12/18/2014 to 1/14/2015.

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. NIHONSAKARI CO., LTD.'s FEI number is 3008436343.

What types of violations has NIHONSAKARI CO., LTD. received?

NIHONSAKARI 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 NIHONSAKARI CO., LTD. come from?

All FDA import refusal data for NIHONSAKARI 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.