Ivemsa
⚠️ High Risk
FEI: 3010718417 • Nelson • MEXICO
FEI Number
3010718417
Location
Nelson
Country
MEXICOAddress
Circuito Internacional Sur No 21, , Nelson, , Mexico
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable violations.
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).
DIRECTIONS
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 3/9/2023 | 73DQAOXIMETER | Division of Northern Border Imports (DNBI) | |
| 3/9/2023 | 73DQAOXIMETER | Division of Northern Border Imports (DNBI) | |
| 3/9/2023 | 73DQAOXIMETER | Division of Northern Border Imports (DNBI) | |
| 3/9/2023 | 73DQAOXIMETER | Division of Northern Border Imports (DNBI) | |
| 3/9/2023 | 73DQAOXIMETER | Division of Northern Border Imports (DNBI) | |
| 3/9/2023 | 74MWIMONITOR, PHYSIOLOGICAL, PATIENT (WITHOUT ARRHYTHMIA DETECTION OR ALARMS) | Division of Northern Border Imports (DNBI) | |
| 3/9/2023 | 73DQAOXIMETER | Division of Northern Border Imports (DNBI) | |
| 5/31/2019 | 80KMIMONITOR, BED PATIENT | Division of Southeast Imports (DSEI) | |
| 5/31/2019 | 80KMIMONITOR, BED PATIENT | Division of Southeast Imports (DSEI) | |
| 5/31/2019 | 80KMIMONITOR, BED PATIENT | Division of Southeast Imports (DSEI) | |
| 5/31/2019 | 80KMIMONITOR, BED PATIENT | Division of Southeast Imports (DSEI) | |
| 5/31/2019 | 80KMIMONITOR, BED PATIENT | Division of Southeast Imports (DSEI) | |
| 5/31/2019 | 80KMIMONITOR, BED PATIENT | Division of Southeast Imports (DSEI) | |
| 5/31/2019 | 80KMIMONITOR, BED PATIENT | Division of Southeast Imports (DSEI) | |
| 5/31/2019 | 80KMIMONITOR, BED PATIENT | Division of Southeast Imports (DSEI) | |
| 5/31/2019 | 80KMIMONITOR, BED PATIENT | Division of Southeast Imports (DSEI) | |
| 5/31/2019 | 80KMIMONITOR, BED PATIENT | Division of Southeast Imports (DSEI) | |
| 5/31/2019 | 80KMIMONITOR, BED PATIENT | Division of Southeast Imports (DSEI) | |
| 5/31/2019 | 80KMIMONITOR, BED PATIENT | Division of Southeast Imports (DSEI) | |
| 5/31/2019 | 80KMIMONITOR, BED PATIENT | Division of Southeast Imports (DSEI) | |
| 5/31/2019 | 80KMIMONITOR, BED PATIENT | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Ivemsa's FDA import refusal history?
Ivemsa (FEI: 3010718417) has 21 FDA import refusal record(s) in our database, spanning from 5/31/2019 to 3/9/2023.
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. Ivemsa's FEI number is 3010718417.
What types of violations has Ivemsa received?
Ivemsa has been cited for 3 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 Ivemsa come from?
All FDA import refusal data for Ivemsa 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.