Art Optical Contact Lens, Inc.
⚠️ Moderate Risk
FEI: 3002340631 • Walker, MI • UNITED STATES
FEI Number
3002340631
Location
Walker, MI
Country
UNITED STATESAddress
3175 3 Mile Rd Nw, , Walker, MI, United States
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 |
|---|---|---|---|
| 7/13/2005 | 86MVNLENS, CONTACT (DISPOSABLE) | 508NO 510(K) | Florida District Office (FLA-DO) |
Frequently Asked Questions
What is Art Optical Contact Lens, Inc.'s FDA import refusal history?
Art Optical Contact Lens, Inc. (FEI: 3002340631) has 1 FDA import refusal record(s) in our database, spanning from 7/13/2005 to 7/13/2005.
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 Optical Contact Lens, Inc.'s FEI number is 3002340631.
What types of violations has Art Optical Contact Lens, Inc. received?
Art Optical Contact Lens, Inc. 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 Art Optical Contact Lens, Inc. come from?
All FDA import refusal data for Art Optical Contact Lens, Inc. 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.