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Nivea-Kao Co., Ltd.

⚠️ Moderate Risk

FEI: 3004788214 • Tokyo • JAPAN

FEI

FEI Number

3004788214

📍

Location

Tokyo

🇯🇵

Country

JAPAN
🏢

Address

R&D Centre Tokyo 4-11-36 Toyo Koto-Ku, , Tokyo, , Japan

Moderate Risk

FDA Import Risk Assessment

29.6
LowModerateHighCritical

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

Statistics

5
Total Refusals
1
Unique Violations
1/4/2005
Latest Refusal
1/4/2005
Earliest Refusal

Score Breakdown

Violation Severity
40.0×40%
Refusal Volume
28.8×30%
Recency
0.0×20%
Frequency
50.0×10%
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

4715×

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
1/4/2005
53LC06MOISTURIZING (SKIN CARE PREPARATIONS)
471CSTIC LBLG
New York District Office (NYK-DO)
1/4/2005
53LC07NIGHT (SKIN CARE PREPARATIONS)
471CSTIC LBLG
New York District Office (NYK-DO)
1/4/2005
53LC06MOISTURIZING (SKIN CARE PREPARATIONS)
471CSTIC LBLG
New York District Office (NYK-DO)
1/4/2005
53LC06MOISTURIZING (SKIN CARE PREPARATIONS)
471CSTIC LBLG
New York District Office (NYK-DO)
1/4/2005
53JD01BATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS)
471CSTIC LBLG
New York District Office (NYK-DO)

Frequently Asked Questions

What is Nivea-Kao Co., Ltd.'s FDA import refusal history?

Nivea-Kao Co., Ltd. (FEI: 3004788214) has 5 FDA import refusal record(s) in our database, spanning from 1/4/2005 to 1/4/2005.

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. Nivea-Kao Co., Ltd.'s FEI number is 3004788214.

What types of violations has Nivea-Kao Co., Ltd. received?

Nivea-Kao 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 Nivea-Kao Co., Ltd. come from?

All FDA import refusal data for Nivea-Kao 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.