Waicon Vision
⚠️ Moderate Risk
FEI: 3011114688 • Buenos Aires, Capital Federal • ARGENTINA
FEI Number
3011114688
Location
Buenos Aires, Capital Federal
Country
ARGENTINAAddress
Calle Juez Juan B Estrada 2781, , Buenos Aires, Capital Federal, Argentina
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).
DIRECTIONS
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.
NO PMA
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the device appears to be a Class III device and does not appear to have in effect an approved application for premarket approval pursuant to Section 515 of the Act, or an exemption pursuant to Section 520(g)(1).
DV NAME
The article appears to be a device and its labeling fails to bear the proprietary or established name.
Refusal History
Frequently Asked Questions
What is Waicon Vision's FDA import refusal history?
Waicon Vision (FEI: 3011114688) has 1 FDA import refusal record(s) in our database, spanning from 12/4/2014 to 12/4/2014.
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. Waicon Vision's FEI number is 3011114688.
What types of violations has Waicon Vision received?
Waicon Vision has been cited for 4 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 Waicon Vision come from?
All FDA import refusal data for Waicon Vision 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.