Optica Tecnos
⚠️ Moderate Risk
FEI: 3004548495 • Mandrid • SPAIN
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
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 |
|---|---|---|---|
| 7/12/2004 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 84RX DEVICE | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Optica Tecnos's FDA import refusal history?
Optica Tecnos (FEI: 3004548495) has 1 FDA import refusal record(s) in our database, spanning from 7/12/2004 to 7/12/2004.
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. Optica Tecnos's FEI number is 3004548495.
What types of violations has Optica Tecnos received?
Optica Tecnos 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 Optica Tecnos come from?
All FDA import refusal data for Optica Tecnos 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.