Venusa de Mexico S. de R.L de C.V
⚠️ Moderate Risk
FEI: 3002808445 • Juarez, Chihuahua • MEXICO
FEI Number
3002808445
Location
Juarez, Chihuahua
Country
MEXICOAddress
CALLE HERTZ 1525, Parque Industrial Antonio J. Bermudez, 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).
INCONSPICU
Information required by the Act to be on the label or labeling does not appear to be conspicuous enough as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use.
NO PMA
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the device appears to be a Class III device and does not appear to have in effect an approved application for premarket approval pursuant to Section 515 of the Act, or an exemption pursuant to Section 520(g)(1).
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).
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
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 |
|---|---|---|---|
| 7/13/2017 | 74LPBCARDIAC ABLATION PERCUTANEOUS CATHETER | Division of Southwest Imports (DSWI) | |
| 7/13/2017 | 74LPBCARDIAC ABLATION PERCUTANEOUS CATHETER | Division of Southwest Imports (DSWI) | |
| 7/13/2017 | 74LPBCARDIAC ABLATION PERCUTANEOUS CATHETER | Division of Southwest Imports (DSWI) | |
| 3/29/2016 | 74OAECATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION | 237NO PMA | New Orleans District Office (NOL-DO) |
| 3/29/2016 | 74OAECATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION | 237NO PMA | New Orleans District Office (NOL-DO) |
| 12/1/2015 | 78KOGENDOSCOPE AND/OR ACCESSORIES | 479DV QUALITY | Southwest Import District Office (SWI-DO) |
| 6/12/2012 | 78OCSENDOSCOPIC VIDEO IMAGING SYSTEM/COMPONENT, GASTROENTEROLOGY-UROLOGY | Southwest Import District Office (SWI-DO) |
Frequently Asked Questions
What is Venusa de Mexico S. de R.L de C.V's FDA import refusal history?
Venusa de Mexico S. de R.L de C.V (FEI: 3002808445) has 7 FDA import refusal record(s) in our database, spanning from 6/12/2012 to 7/13/2017.
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. Venusa de Mexico S. de R.L de C.V's FEI number is 3002808445.
What types of violations has Venusa de Mexico S. de R.L de C.V received?
Venusa de Mexico S. de R.L de C.V has been cited for 6 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 Venusa de Mexico S. de R.L de C.V come from?
All FDA import refusal data for Venusa de Mexico S. de R.L de C.V 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.