Maria De Lourdes Garcia Elizal
⚠️ Moderate Risk
FEI: 3004145289 • Ciudad De Mexico, Ciudad de Mexico • MEXICO
FEI Number
3004145289
Location
Ciudad De Mexico, Ciudad de Mexico
Country
MEXICOAddress
Avenida Vito Alessio Robles # 34, Col. Florida, Alvaro Obregon, Ciudad De Mexico, Ciudad de Mexico, 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 |
|---|---|---|---|
| 10/17/2003 | 86HQDLENS, CONTACT (OTHER MATERIAL) - DAILY | 508NO 510(K) | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Maria De Lourdes Garcia Elizal's FDA import refusal history?
Maria De Lourdes Garcia Elizal (FEI: 3004145289) has 1 FDA import refusal record(s) in our database, spanning from 10/17/2003 to 10/17/2003.
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. Maria De Lourdes Garcia Elizal's FEI number is 3004145289.
What types of violations has Maria De Lourdes Garcia Elizal received?
Maria De Lourdes Garcia Elizal 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 Maria De Lourdes Garcia Elizal come from?
All FDA import refusal data for Maria De Lourdes Garcia Elizal 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.