Ambulance Network Inc.
⚠️ Moderate Risk
FEI: 3002904506 • Miami, FL • UNITED STATES
FEI Number
3002904506
Location
Miami, FL
Country
UNITED STATESAddress
3450 NW 36th St, , Miami, FL, United States
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).
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).
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 |
|---|---|---|---|
| 5/24/2012 | 73OLFPORTABLE OXYGEN GENERATOR | Division of Southeast Imports (DSEI) | |
| 5/24/2012 | 73OLFPORTABLE OXYGEN GENERATOR | Division of Southeast Imports (DSEI) | |
| 5/24/2012 | 80OYSPATIENT BED WITH CANOPY/RESTRAINTS | 118NOT LISTED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Ambulance Network Inc.'s FDA import refusal history?
Ambulance Network Inc. (FEI: 3002904506) has 3 FDA import refusal record(s) in our database, spanning from 5/24/2012 to 5/24/2012.
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. Ambulance Network Inc.'s FEI number is 3002904506.
What types of violations has Ambulance Network Inc. received?
Ambulance Network Inc. 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 Ambulance Network Inc. come from?
All FDA import refusal data for Ambulance Network 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.