Art Vision
⚠️ Moderate Risk
FEI: 3003499043 • Hattingen, North Rhine-Westphalia • GERMANY
FEI Number
3003499043
Location
Hattingen, North Rhine-Westphalia
Country
GERMANYAddress
Huttenstr. 45, , Hattingen, North Rhine-Westphalia, Germany
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
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).
NOT IMPACT
The article appears to not have impact-resistant lenses in accordance with 21 CFR 801.410.
RX DEVICE
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a prescription device that appears to not feature a prescription device legend as required by 21 CFR 801.109.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/16/2003 | 86HQGLENS, SPECTACLE, NON-CUSTOM (PRESCRIPTION) | 84RX DEVICE | New Orleans District Office (NOL-DO) |
| 6/20/2002 | 86HQGLENS, SPECTACLE, NON-CUSTOM (PRESCRIPTION) | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 10/30/2001 | 86HQGLENS, SPECTACLE, NON-CUSTOM (PRESCRIPTION) | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is Art Vision's FDA import refusal history?
Art Vision (FEI: 3003499043) has 3 FDA import refusal record(s) in our database, spanning from 10/30/2001 to 12/16/2003.
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. Art Vision's FEI number is 3003499043.
What types of violations has Art Vision received?
Art Vision has been cited for 3 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 Art Vision come from?
All FDA import refusal data for Art Vision 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.