INDISTRIAL VALLERA DE MEXICALI S
⚠️ High Risk
FEI: 3018205925 • Mexicali • MEXICO
FEI Number
3018205925
Location
Mexicali
Country
MEXICOAddress
Calzada Del Oro Pa 2201, , Mexicali, , 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).
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 1/22/2026 | 74MWIMONITOR, PHYSIOLOGICAL, PATIENT (WITHOUT ARRHYTHMIA DETECTION OR ALARMS) | Division of Southeast Imports (DSEI) | |
| 1/22/2026 | 74MWIMONITOR, PHYSIOLOGICAL, PATIENT (WITHOUT ARRHYTHMIA DETECTION OR ALARMS) | Division of Southeast Imports (DSEI) | |
| 1/22/2026 | 73DQAOXIMETER | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is INDISTRIAL VALLERA DE MEXICALI S's FDA import refusal history?
INDISTRIAL VALLERA DE MEXICALI S (FEI: 3018205925) has 3 FDA import refusal record(s) in our database, spanning from 1/22/2026 to 1/22/2026.
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. INDISTRIAL VALLERA DE MEXICALI S's FEI number is 3018205925.
What types of violations has INDISTRIAL VALLERA DE MEXICALI S received?
INDISTRIAL VALLERA DE MEXICALI S has been cited for 2 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 INDISTRIAL VALLERA DE MEXICALI S come from?
All FDA import refusal data for INDISTRIAL VALLERA DE MEXICALI S 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.