Vistakon, Inc.
⚠️ Moderate Risk
FEI: 1024871 • Jacksonville, FL • UNITED STATES
FEI Number
1024871
Location
Jacksonville, FL
Country
UNITED STATESAddress
1417 San Marco Blvd, , Jacksonville, 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
RX DEVICE
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a prescription device that appears to not feature a prescription device legend as required by 21 CFR 801.109.
Refusal History
Frequently Asked Questions
What is Vistakon, Inc.'s FDA import refusal history?
Vistakon, Inc. (FEI: 1024871) has 2 FDA import refusal record(s) in our database, spanning from 11/20/2003 to 11/18/2004.
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. Vistakon, Inc.'s FEI number is 1024871.
What types of violations has Vistakon, Inc. received?
Vistakon, Inc. 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 Vistakon, Inc. come from?
All FDA import refusal data for Vistakon, 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.