Card Products Sa De Cv
⚠️ Moderate Risk
FEI: 3007838294 • Reynosa • MEXICO
FEI Number
3007838294
Location
Reynosa
Country
MEXICOAddress
Blvd Rivera Central 240, , Reynosa, , 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
REGISTERED
It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 1/17/2012 | 80FLGCLEANER, ULTRASONIC, MEDICAL INSTRUMENT | 341REGISTERED | Southwest Import District Office (SWI-DO) |
| 1/17/2012 | 85HEKMONITOR, HEART SOUND, FETAL, ULTRASONIC | 341REGISTERED | Southwest Import District Office (SWI-DO) |
| 1/17/2012 | 85HEKMONITOR, HEART SOUND, FETAL, ULTRASONIC | 341REGISTERED | Southwest Import District Office (SWI-DO) |
| 1/17/2012 | 80FLGCLEANER, ULTRASONIC, MEDICAL INSTRUMENT | 341REGISTERED | Southwest Import District Office (SWI-DO) |
| 1/17/2012 | 80FLGCLEANER, ULTRASONIC, MEDICAL INSTRUMENT | 341REGISTERED | Southwest Import District Office (SWI-DO) |
| 1/17/2012 | 80FLGCLEANER, ULTRASONIC, MEDICAL INSTRUMENT | 341REGISTERED | Southwest Import District Office (SWI-DO) |
Frequently Asked Questions
What is Card Products Sa De Cv's FDA import refusal history?
Card Products Sa De Cv (FEI: 3007838294) has 6 FDA import refusal record(s) in our database, spanning from 1/17/2012 to 1/17/2012.
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. Card Products Sa De Cv's FEI number is 3007838294.
What types of violations has Card Products Sa De Cv received?
Card Products 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 Card Products Sa De Cv come from?
All FDA import refusal data for Card Products 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.