MICROVENTION INC.
⚠️ High Risk
FEI: 3013556777 • Aliso Viejo, CA • UNITED STATES
FEI Number
3013556777
Location
Aliso Viejo, CA
Country
UNITED STATESAddress
35 Enterprise, , Aliso Viejo, CA, United States
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
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.
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 4/15/2025 | 84HCGDEVICE, ARTIFICIAL EMBOLIZATION | 3280FRNMFGREG | Division of West Coast Imports (DWCI) |
| 4/15/2025 | 84HCGDEVICE, ARTIFICIAL EMBOLIZATION | 3280FRNMFGREG | Division of West Coast Imports (DWCI) |
| 4/15/2025 | 84HCGDEVICE, ARTIFICIAL EMBOLIZATION | 3280FRNMFGREG | Division of West Coast Imports (DWCI) |
| 4/15/2025 | 84HCGDEVICE, ARTIFICIAL EMBOLIZATION | 3280FRNMFGREG | Division of West Coast Imports (DWCI) |
| 4/8/2025 | 74DQXWIRE, GUIDE, CATHETER | 3280FRNMFGREG | Division of West Coast Imports (DWCI) |
| 3/24/2025 | 84HCGDEVICE, ARTIFICIAL EMBOLIZATION | 3280FRNMFGREG | Division of West Coast Imports (DWCI) |
| 3/24/2025 | 84HCGDEVICE, ARTIFICIAL EMBOLIZATION | 3280FRNMFGREG | Division of West Coast Imports (DWCI) |
| 3/24/2025 | 84HCGDEVICE, ARTIFICIAL EMBOLIZATION | 3280FRNMFGREG | Division of West Coast Imports (DWCI) |
| 3/24/2025 | 84HCGDEVICE, ARTIFICIAL EMBOLIZATION | 3280FRNMFGREG | Division of West Coast Imports (DWCI) |
| 3/14/2025 | 74NTECATHETER, CAROTID, TEMPORARY, FOR EMBOLIZATION CAPTURE | Division of Southeast Imports (DSEI) | |
| 3/14/2025 | 74NTECATHETER, CAROTID, TEMPORARY, FOR EMBOLIZATION CAPTURE | Division of Southeast Imports (DSEI) | |
| 3/14/2025 | 74NTECATHETER, CAROTID, TEMPORARY, FOR EMBOLIZATION CAPTURE | Division of Southeast Imports (DSEI) | |
| 3/14/2025 | 74NTECATHETER, CAROTID, TEMPORARY, FOR EMBOLIZATION CAPTURE | Division of Southeast Imports (DSEI) | |
| 3/14/2025 | 74NTECATHETER, CAROTID, TEMPORARY, FOR EMBOLIZATION CAPTURE | Division of Southeast Imports (DSEI) | |
| 3/14/2025 | 74NTECATHETER, CAROTID, TEMPORARY, FOR EMBOLIZATION CAPTURE | Division of Southeast Imports (DSEI) | |
| 3/14/2025 | 74NTECATHETER, CAROTID, TEMPORARY, FOR EMBOLIZATION CAPTURE | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is MICROVENTION INC.'s FDA import refusal history?
MICROVENTION INC. (FEI: 3013556777) has 16 FDA import refusal record(s) in our database, spanning from 3/14/2025 to 4/15/2025.
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. MICROVENTION INC.'s FEI number is 3013556777.
What types of violations has MICROVENTION INC. received?
MICROVENTION INC. 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 MICROVENTION INC. come from?
All FDA import refusal data for MICROVENTION INC. 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.