Proxy Biomedical Ltd.
⚠️ Moderate Risk
FEI: 3004859928 • Galway, Co. GALWAY • IRELAND
FEI Number
3004859928
Location
Galway, Co. GALWAY
Country
IRELANDAddress
Coilleach, Spiddal, Galway, Co. GALWAY, 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
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).
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).
NO REGISTR
The article appears to be an electronic product that does not comply with an applicable standard as prescribed by Section 534 because no reporting has been provided as required by Section 537(b).
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 7/18/2024 | 78OTNMESH, SURGICAL, GYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, FEMALE | Division of Southeast Imports (DSEI) | |
| 6/13/2023 | 89ILISLING, ARM | 476NO REGISTR | Division of Southeast Imports (DSEI) |
| 9/7/2012 | 79MDMINSTRUMENT, MANUAL, GENERAL SURGICAL | 118NOT LISTED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Proxy Biomedical Ltd.'s FDA import refusal history?
Proxy Biomedical Ltd. (FEI: 3004859928) has 3 FDA import refusal record(s) in our database, spanning from 9/7/2012 to 7/18/2024.
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. Proxy Biomedical Ltd.'s FEI number is 3004859928.
What types of violations has Proxy Biomedical Ltd. received?
Proxy Biomedical 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 Proxy Biomedical Ltd. come from?
All FDA import refusal data for Proxy Biomedical 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.