Acucon
✅ Low Risk
FEI: 3005184723 • Sarasota, FL • UNITED STATES
FEI Number
3005184723
Location
Sarasota, FL
Country
UNITED STATESAddress
7455 16th St E Ste 108, , Sarasota, FL, United States
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
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 801.15(c)(1)
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 8/12/2013 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 3260NO ENGLISH | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Acucon's FDA import refusal history?
Acucon (FEI: 3005184723) has 1 FDA import refusal record(s) in our database, spanning from 8/12/2013 to 8/12/2013.
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. Acucon's FEI number is 3005184723.
What types of violations has Acucon received?
Acucon 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 Acucon come from?
All FDA import refusal data for Acucon 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.