Fujifilm Visualsonics, Inc.
⚠️ Moderate Risk
FEI: 3003774756 • Toronto, Ontario • CANADA
FEI Number
3003774756
Location
Toronto, Ontario
Country
CANADAAddress
3080 Yonge St Suite 6100, , Toronto, Ontario, 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
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).
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).
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).
Refusal History
Frequently Asked Questions
What is Fujifilm Visualsonics, Inc.'s FDA import refusal history?
Fujifilm Visualsonics, Inc. (FEI: 3003774756) has 1 FDA import refusal record(s) in our database, spanning from 10/11/2013 to 10/11/2013.
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. Fujifilm Visualsonics, Inc.'s FEI number is 3003774756.
What types of violations has Fujifilm Visualsonics, Inc. received?
Fujifilm Visualsonics, 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 Fujifilm Visualsonics, Inc. come from?
All FDA import refusal data for Fujifilm Visualsonics, 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.