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Skii

⚠️ Moderate Risk

FEI: 3003897971 • Naka, Ibaraki • JAPAN

FEI

FEI Number

3003897971

📍

Location

Naka, Ibaraki

🇯🇵

Country

JAPAN
🏢

Address

1 Chome 17, Takenochi, Naka, Ibaraki, Japan

Moderate Risk

FDA Import Risk Assessment

26.9
LowModerateHighCritical

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

Statistics

7
Total Refusals
2
Unique Violations
2/5/2013
Latest Refusal
11/18/2004
Earliest Refusal

Score Breakdown

Violation Severity
40.0×40%
Refusal Volume
33.5×30%
Recency
0.0×20%
Frequency
8.5×10%
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

4716×

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.

4751×

COSMETLBLG

It appears that the cosmetic consists of two or more ingredients and the label does not list the common or usual name of each ingredient.

Refusal History

DateProductViolationsDivision
2/5/2013
53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS)
471CSTIC LBLG
Los Angeles District Office (LOS-DO)
2/5/2013
53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS)
471CSTIC LBLG
Los Angeles District Office (LOS-DO)
2/5/2013
53LD01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS)
471CSTIC LBLG
Los Angeles District Office (LOS-DO)
2/5/2013
53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS)
471CSTIC LBLG
Los Angeles District Office (LOS-DO)
2/5/2013
53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS)
471CSTIC LBLG
Los Angeles District Office (LOS-DO)
2/5/2013
53LD03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS)
471CSTIC LBLG
Los Angeles District Office (LOS-DO)
11/18/2004
53LY99OTHER SKIN CARE PREPARATIONS, N.E.C.
475COSMETLBLG
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is Skii's FDA import refusal history?

Skii (FEI: 3003897971) has 7 FDA import refusal record(s) in our database, spanning from 11/18/2004 to 2/5/2013.

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. Skii's FEI number is 3003897971.

What types of violations has Skii received?

Skii 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 Skii come from?

All FDA import refusal data for Skii 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.