Cara Dimex S.A De Cv
⚠️ Moderate Risk
FEI: 3003534256 • Cuauhtemoc • 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
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 |
|---|---|---|---|
| 3/19/2002 | 86HQGLENS, SPECTACLE, NON-CUSTOM (PRESCRIPTION) | 84RX DEVICE | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Cara Dimex S.A De Cv's FDA import refusal history?
Cara Dimex S.A De Cv (FEI: 3003534256) has 1 FDA import refusal record(s) in our database, spanning from 3/19/2002 to 3/19/2002.
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. Cara Dimex S.A De Cv's FEI number is 3003534256.
What types of violations has Cara Dimex S.A De Cv received?
Cara Dimex S.A 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 Cara Dimex S.A De Cv come from?
All FDA import refusal data for Cara Dimex 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.