DR ARRIVO GHOST PREMIUM ARTISTIC
⚠️ Moderate Risk
FEI: 3025566853 • Gifu • JAPAN
Moderate Risk
FDA Import Risk Assessment
This firm has a moderate history of FDA import refusals. Some attention may be warranted.
Statistics
Score Breakdown
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
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
| Date | Product | Violations | Division |
|---|---|---|---|
| 3/29/2023 | 79OHSLIGHT BASED OVER THE COUNTER WRINKLE REDUCTION | 508NO 510(K) | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is DR ARRIVO GHOST PREMIUM ARTISTIC's FDA import refusal history?
DR ARRIVO GHOST PREMIUM ARTISTIC (FEI: 3025566853) has 1 FDA import refusal record(s) in our database, spanning from 3/29/2023 to 3/29/2023.
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. DR ARRIVO GHOST PREMIUM ARTISTIC's FEI number is 3025566853.
What types of violations has DR ARRIVO GHOST PREMIUM ARTISTIC received?
DR ARRIVO GHOST PREMIUM ARTISTIC 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 DR ARRIVO GHOST PREMIUM ARTISTIC come from?
All FDA import refusal data for DR ARRIVO GHOST PREMIUM ARTISTIC 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.