Spectral Medical Inc.
⚠️ Moderate Risk
FEI: 3000058367 • Toronto, Ontario • CANADA
FEI Number
3000058367
Location
Toronto, Ontario
Country
CANADAAddress
135-2 The West Mall, Unit 2, 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).
FILTHY
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the article appears to consist in whole or in part of a filthy, putrid, or decomposed substance or be otherwise unfit for food.
Refusal History
Frequently Asked Questions
What is Spectral Medical Inc.'s FDA import refusal history?
Spectral Medical Inc. (FEI: 3000058367) has 2 FDA import refusal record(s) in our database, spanning from 7/3/2002 to 10/3/2002.
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. Spectral Medical Inc.'s FEI number is 3000058367.
What types of violations has Spectral Medical Inc. received?
Spectral Medical Inc. 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 Spectral Medical Inc. come from?
All FDA import refusal data for Spectral Medical 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.