Alliance Vision Clinic
⚠️ Moderate Risk
FEI: 3003871656 • Moncton, NB • CANADA
FEI Number
3003871656
Location
Moncton, NB
Country
CANADAAddress
340 Mountain Rd, , Moncton, NB, Canada
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
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.
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 Alliance Vision Clinic's FDA import refusal history?
Alliance Vision Clinic (FEI: 3003871656) has 1 FDA import refusal record(s) in our database, spanning from 2/3/2003 to 2/3/2003.
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. Alliance Vision Clinic's FEI number is 3003871656.
What types of violations has Alliance Vision Clinic received?
Alliance Vision Clinic 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 Alliance Vision Clinic come from?
All FDA import refusal data for Alliance Vision Clinic 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.