Polimeros Opticos De Mexico Sa De Cv
⚠️ Moderate Risk
FEI: 3003769929 • Col • MEXICO
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 |
|---|---|---|---|
| 4/9/2003 | 86MJPLENS, INTRAOCULAR, TORIC OPTICS | 508NO 510(K) | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Polimeros Opticos De Mexico Sa De Cv's FDA import refusal history?
Polimeros Opticos De Mexico Sa De Cv (FEI: 3003769929) has 1 FDA import refusal record(s) in our database, spanning from 4/9/2003 to 4/9/2003.
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. Polimeros Opticos De Mexico Sa De Cv's FEI number is 3003769929.
What types of violations has Polimeros Opticos De Mexico Sa De Cv received?
Polimeros Opticos De Mexico Sa De Cv 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 Polimeros Opticos De Mexico Sa De Cv come from?
All FDA import refusal data for Polimeros Opticos De Mexico Sa De Cv 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.