MASIMO INDUSTRIAL VALLERA DE MEX
✅ Low Risk
FEI: 3016618415 • Mexicali • MEXICO
FEI Number
3016618415
Location
Mexicali
Country
MEXICOAddress
Sa De Cv Calzada Del Or, , Mexicali, , Mexico
Low Risk
FDA Import Risk Assessment
This firm has a minimal history of FDA import refusals with low-severity 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
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 |
|---|---|---|---|
| 6/7/2021 | 74MWIMONITOR, PHYSIOLOGICAL, PATIENT (WITHOUT ARRHYTHMIA DETECTION OR ALARMS) | 3280FRNMFGREG | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is MASIMO INDUSTRIAL VALLERA DE MEX's FDA import refusal history?
MASIMO INDUSTRIAL VALLERA DE MEX (FEI: 3016618415) has 1 FDA import refusal record(s) in our database, spanning from 6/7/2021 to 6/7/2021.
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. MASIMO INDUSTRIAL VALLERA DE MEX's FEI number is 3016618415.
What types of violations has MASIMO INDUSTRIAL VALLERA DE MEX received?
MASIMO INDUSTRIAL VALLERA DE MEX 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 MASIMO INDUSTRIAL VALLERA DE MEX come from?
All FDA import refusal data for MASIMO INDUSTRIAL VALLERA DE MEX 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.