Vivomed Ltd
⚠️ Moderate Risk
FEI: 3008216164 • Downpatrick, County Down • UNITED KINGDOM
FEI Number
3008216164
Location
Downpatrick, County Down
Country
UNITED KINGDOMAddress
2 Brannish Road, , Downpatrick, County Down, United Kingdom
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).
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.
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 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 |
|---|---|---|---|
| 5/16/2019 | 79KGXTAPE AND BANDAGE, ADHESIVE | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 4/24/2015 | 79MPNTISSUE ADHESIVE FOR SOFT TISSUE APPROXIMATION | Division of Southeast Imports (DSEI) | |
| 2/23/2015 | 80FOZCATHETER, INTRAVASCULAR, SHORT TERM | Division of Southeast Imports (DSEI) | |
| 2/23/2015 | 80FMINEEDLE, HYPODERMIC, SINGLE LUMEN | Division of Southeast Imports (DSEI) | |
| 12/19/2014 | 79KGXTAPE AND BANDAGE, ADHESIVE | New Orleans District Office (NOL-DO) | |
| 7/16/2014 | 80LDQDEVICE, GENERAL MEDICAL | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Vivomed Ltd's FDA import refusal history?
Vivomed Ltd (FEI: 3008216164) has 6 FDA import refusal record(s) in our database, spanning from 7/16/2014 to 5/16/2019.
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. Vivomed Ltd's FEI number is 3008216164.
What types of violations has Vivomed Ltd received?
Vivomed 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 Vivomed Ltd come from?
All FDA import refusal data for Vivomed 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.