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Home Art & Sales

⚠️ Moderate Risk

FEI: 3004027986 • Wollerau, Schwyz • SWITZERLAND

FEI

FEI Number

3004027986

📍

Location

Wollerau, Schwyz

🇨🇭
🏢

Address

Sihleggstrasse 23, , Wollerau, Schwyz, Switzerland

Moderate Risk

FDA Import Risk Assessment

37.7
LowModerateHighCritical

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

Statistics

3
Total Refusals
1
Unique Violations
2/12/2008
Latest Refusal
2/12/2008
Earliest Refusal

Score Breakdown

Violation Severity
70.0×40%
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

5083×

NO 510(K)

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.

Refusal History

DateProductViolationsDivision
2/12/2008
79MXGLAMP, UVC (FOR TREATING SKIN AND WOUNDS)
508NO 510(K)
Los Angeles District Office (LOS-DO)
2/12/2008
79MXGLAMP, UVC (FOR TREATING SKIN AND WOUNDS)
508NO 510(K)
Los Angeles District Office (LOS-DO)
2/12/2008
79MXGLAMP, UVC (FOR TREATING SKIN AND WOUNDS)
508NO 510(K)
Los Angeles District Office (LOS-DO)

Frequently Asked Questions

What is Home Art & Sales's FDA import refusal history?

Home Art & Sales (FEI: 3004027986) has 3 FDA import refusal record(s) in our database, spanning from 2/12/2008 to 2/12/2008.

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. Home Art & Sales's FEI number is 3004027986.

What types of violations has Home Art & Sales received?

Home Art & Sales 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 Home Art & Sales come from?

All FDA import refusal data for Home Art & Sales 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.