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Wamiles Cosmetics

⚠️ Moderate Risk

FEI: 1000372344 • Yokohama, Kanagawa • JAPAN

FEI

FEI Number

1000372344

📍

Location

Yokohama, Kanagawa

🇯🇵

Country

JAPAN
🏢

Address

7-16 Konanchuodori, Konanchuodori; Konan, Yokohama, Kanagawa, Japan

Moderate Risk

FDA Import Risk Assessment

27.2
LowModerateHighCritical

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

Statistics

2
Total Refusals
1
Unique Violations
8/23/2004
Latest Refusal
8/5/2003
Earliest Refusal

Score Breakdown

Violation Severity
50.0×40%
Refusal Volume
17.7×30%
Recency
0.0×20%
Frequency
19.0×10%
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

1182×

NOT LISTED

It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).

Refusal History

DateProductViolationsDivision
8/23/2004
66VCJ99MISCELLANEOUS PATENT MEDICINES, ETC.
118NOT LISTED
Los Angeles District Office (LOS-DO)
8/5/2003
66PBY99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C.
118NOT LISTED
Los Angeles District Office (LOS-DO)

Frequently Asked Questions

What is Wamiles Cosmetics's FDA import refusal history?

Wamiles Cosmetics (FEI: 1000372344) has 2 FDA import refusal record(s) in our database, spanning from 8/5/2003 to 8/23/2004.

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. Wamiles Cosmetics's FEI number is 1000372344.

What types of violations has Wamiles Cosmetics received?

Wamiles Cosmetics 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 Wamiles Cosmetics come from?

All FDA import refusal data for Wamiles Cosmetics 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.