Lake Region Medical, Ltd.
⚠️ Moderate Risk
FEI: 3002807439 • New Ross, Co. WEXFORD • IRELAND
FEI Number
3002807439
Location
New Ross, Co. WEXFORD
Country
IRELANDAddress
Father Butler Park, BUTLERSLAND, New Ross, Co. WEXFORD, Ireland
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
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).
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.
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 11/27/2020 | 74DQXWIRE, GUIDE, CATHETER | Division of Northern Border Imports (DNBI) | |
| 4/17/2020 | 74DQXWIRE, GUIDE, CATHETER | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 9/6/2019 | 74DQXWIRE, GUIDE, CATHETER | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 6/24/2019 | 74OFBCATHETER GUIDE WIRE KIT | Division of Southeast Imports (DSEI) | |
| 6/4/2019 | 74DQXWIRE, GUIDE, CATHETER | 341REGISTERED | Division of Northern Border Imports (DNBI) |
| 6/3/2019 | 74DQXWIRE, GUIDE, CATHETER | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 6/3/2019 | 74DQXWIRE, GUIDE, CATHETER | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 6/3/2019 | 74DQXWIRE, GUIDE, CATHETER | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 6/3/2019 | 74DQXWIRE, GUIDE, CATHETER | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 6/3/2019 | 74DQXWIRE, GUIDE, CATHETER | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 6/3/2019 | 74DQXWIRE, GUIDE, CATHETER | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 6/3/2019 | 74DQXWIRE, GUIDE, CATHETER | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 6/3/2019 | 74DQXWIRE, GUIDE, CATHETER | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 6/3/2019 | 74DQXWIRE, GUIDE, CATHETER | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 6/3/2019 | 74DQXWIRE, GUIDE, CATHETER | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 6/3/2019 | 74DQXWIRE, GUIDE, CATHETER | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 6/3/2019 | 74DQXWIRE, GUIDE, CATHETER | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 6/3/2019 | 74DQXWIRE, GUIDE, CATHETER | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 5/2/2019 | 74DQXWIRE, GUIDE, CATHETER | 341REGISTERED | Division of West Coast Imports (DWCI) |
| 9/1/2016 | 74DQXWIRE, GUIDE, CATHETER | 341REGISTERED | New Orleans District Office (NOL-DO) |
| 9/1/2016 | 74DQXWIRE, GUIDE, CATHETER | 341REGISTERED | New Orleans District Office (NOL-DO) |
| 9/1/2016 | 74DQXWIRE, GUIDE, CATHETER | 341REGISTERED | New Orleans District Office (NOL-DO) |
| 9/1/2016 | 74DQXWIRE, GUIDE, CATHETER | 341REGISTERED | New Orleans District Office (NOL-DO) |
| 9/1/2016 | 74DQXWIRE, GUIDE, CATHETER | 341REGISTERED | New Orleans District Office (NOL-DO) |
| 6/18/2012 | 78KNYACCESSORIES, CATHETER, G-U | 341REGISTERED | New Orleans District Office (NOL-DO) |
| 2/7/2005 | 87LRNWIRE, SURGICAL | Division of Southeast Imports (DSEI) | |
| 2/7/2005 | 87LRNWIRE, SURGICAL | 341REGISTERED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Lake Region Medical, Ltd.'s FDA import refusal history?
Lake Region Medical, Ltd. (FEI: 3002807439) has 27 FDA import refusal record(s) in our database, spanning from 2/7/2005 to 11/27/2020.
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. Lake Region Medical, Ltd.'s FEI number is 3002807439.
What types of violations has Lake Region Medical, Ltd. received?
Lake Region Medical, Ltd. 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 Lake Region Medical, Ltd. come from?
All FDA import refusal data for Lake Region Medical, Ltd. 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.