Demophorius Limited
⚠️ Moderate Risk
FEI: 3010712963 • Lemesos, Lemesos • CYPRUS
FEI Number
3010712963
Location
Lemesos, Lemesos
Country
CYPRUSAddress
Archiepiskopou Makariou C' Avenue 196, , Lemesos, Lemesos, Cyprus
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).
DEVICEGMPS
The article is subject to refusal of admission pursuant to Section 801(a)(1) in that the methods used in, or the facilities or controls used for, the manufacture, packing, storage, or installation of the device do not conform to the requirements of Section 520(f)(1) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) or a condition prescribed by an order under section 520(f)(2) of the FD&C Act.
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.
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.
NO LICENSE
The article is subject to refusal of admission under section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) because it appears to be a biological product for which a biologics license is not in effect under the Public Health Service Act, Part F, Subpart 1-Biological Products, Section 351(a), and it is not the subject of an Investigational New Drug application that is in effect. Therefore, it appears to be a new drug under 201(p) of the FD&C Act that it is in violation of section 505(a) of the FD&C Act because it lacks a new drug approval and because it is misbranded under section 502(f)(1)of the FD&C Act because it fails to bear adequate directions for use
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 1/4/2022 | 78KNXCOLLECTOR, URINE, (AND ACCESSORIES) FOR INDWELLING CATHETER | 2780DEVICEGMPS | Division of Southeast Imports (DSEI) |
| 2/2/2017 | 57YH02BLOOD BAGS WITH ANTI-COAGULANT PRIOR TO USE | 71NO LICENSE | Division of Southeast Imports (DSEI) |
| 5/14/2014 | 80BRZSET, BLOOD TRANSFUSION | Florida District Office (FLA-DO) |
Frequently Asked Questions
What is Demophorius Limited's FDA import refusal history?
Demophorius Limited (FEI: 3010712963) has 3 FDA import refusal record(s) in our database, spanning from 5/14/2014 to 1/4/2022.
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. Demophorius Limited's FEI number is 3010712963.
What types of violations has Demophorius Limited received?
Demophorius Limited has been cited for 5 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 Demophorius Limited come from?
All FDA import refusal data for Demophorius Limited 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.