American Optical De Mexico S A De Cv
⚠️ Moderate Risk
FEI: 3003610121 • Naucalpan Mexico • MEXICO
FEI Number
3003610121
Location
Naucalpan Mexico
Country
MEXICOAddress
Proton 12, , Naucalpan 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
NOT IMPACT
The article appears to not have impact-resistant lenses in accordance with 21 CFR 801.410.
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).
Refusal History
Frequently Asked Questions
What is American Optical De Mexico S A De Cv's FDA import refusal history?
American Optical De Mexico S A De Cv (FEI: 3003610121) has 2 FDA import refusal record(s) in our database, spanning from 5/20/2002 to 5/20/2002.
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. American Optical De Mexico S A De Cv's FEI number is 3003610121.
What types of violations has American Optical De Mexico S A De Cv received?
American Optical De Mexico S A De Cv has been cited for 2 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 American Optical De Mexico S A De Cv come from?
All FDA import refusal data for American Optical De Mexico S A 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.