Cardinal Health Mexico 244 S de RL de CV
⚠️ Moderate Risk
FEI: 3003528016 • Juarez, Chihuahua • MEXICO
FEI Number
3003528016
Location
Juarez, Chihuahua
Country
MEXICOAddress
Santiago Troncoso #808, PARQUE INDUSTRIAL SALVARCAR, Juarez, Chihuahua, 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 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).
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.
INVDEVICE
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a device for investigational use for which no exemption has been granted as prescribed by Section 520(g)
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).
DV QUALITY
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be adulterated since its strength differs from, or its purity or quality falls below, that which it purports or is represented to possess.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 4/17/2020 | 74DYBINTRODUCER, CATHETER | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 4/17/2020 | 74DQYCATHETER, PERCUTANEOUS | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 8/6/2018 | 74DYBINTRODUCER, CATHETER | 479DV QUALITY | Division of Southwest Imports (DSWI) |
| 4/22/2016 | 74MGBDEVICE, HEMOSTASIS, VASCULAR | 3081INVDEVICE | Division of Southwest Imports (DSWI) |
| 4/22/2016 | 74LPBCARDIAC ABLATION PERCUTANEOUS CATHETER | 118NOT LISTED | Division of Southwest Imports (DSWI) |
| 1/15/2016 | 74LOXCATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS & OPERATIVE | 118NOT LISTED | Southwest Import District Office (SWI-DO) |
| 1/15/2016 | 74LOXCATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS & OPERATIVE | 118NOT LISTED | Southwest Import District Office (SWI-DO) |
| 1/15/2016 | 74LOXCATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS & OPERATIVE | 118NOT LISTED | Southwest Import District Office (SWI-DO) |
| 1/15/2016 | 74LOXCATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS & OPERATIVE | 118NOT LISTED | Southwest Import District Office (SWI-DO) |
| 1/15/2016 | 74LOXCATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS & OPERATIVE | 118NOT LISTED | Southwest Import District Office (SWI-DO) |
| 2/9/2007 | 74MAFSTENT, CARDIOVASCULAR | Florida District Office (FLA-DO) | |
| 7/7/2006 | 74MAFSTENT, CARDIOVASCULAR | Florida District Office (FLA-DO) |
Frequently Asked Questions
What is Cardinal Health Mexico 244 S de RL de CV's FDA import refusal history?
Cardinal Health Mexico 244 S de RL de CV (FEI: 3003528016) has 12 FDA import refusal record(s) in our database, spanning from 7/7/2006 to 4/17/2020.
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. Cardinal Health Mexico 244 S de RL de CV's FEI number is 3003528016.
What types of violations has Cardinal Health Mexico 244 S de RL de CV received?
Cardinal Health Mexico 244 S de RL de CV has been cited for 5 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 Cardinal Health Mexico 244 S de RL de CV come from?
All FDA import refusal data for Cardinal Health Mexico 244 S de RL 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.