Ludlow Technical Products Canada Ltd(A Division of Cardinal Health)
⚠️ Moderate Risk
FEI: 3003491392 • Gananoque, Ontario • CANADA
FEI Number
3003491392
Location
Gananoque, Ontario
Country
CANADAAddress
215 Herbert St, , Gananoque, 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 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.
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
| Date | Product | Violations | Division |
|---|---|---|---|
| 9/29/2025 | 74DRXELECTRODE, ELECTROCARDIOGRAPH | Division of Southeast Imports (DSEI) | |
| 3/24/2023 | 85HGPELECTRODE, CIRCULAR (SPIRAL), SCALP AND APPLICATOR | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 12/29/2011 | 74DRXELECTRODE, ELECTROCARDIOGRAPH | Detroit District Office (DET-DO) | |
| 10/29/2004 | 79LWKRAZOR, SURGICAL | 118NOT LISTED | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is Ludlow Technical Products Canada Ltd(A Division of Cardinal Health)'s FDA import refusal history?
Ludlow Technical Products Canada Ltd(A Division of Cardinal Health) (FEI: 3003491392) has 4 FDA import refusal record(s) in our database, spanning from 10/29/2004 to 9/29/2025.
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. Ludlow Technical Products Canada Ltd(A Division of Cardinal Health)'s FEI number is 3003491392.
What types of violations has Ludlow Technical Products Canada Ltd(A Division of Cardinal Health) received?
Ludlow Technical Products Canada Ltd(A Division of Cardinal Health) 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 Ludlow Technical Products Canada Ltd(A Division of Cardinal Health) come from?
All FDA import refusal data for Ludlow Technical Products Canada Ltd(A Division of Cardinal Health) 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.