DEMOPHORIOUS LTD.
⚠️ Moderate Risk
FEI: 3013438661 • Limassol • CYPRUS
FEI Number
3013438661
Location
Limassol
Country
CYPRUSAddress
196 Archbishop Makariosiii Ave, , Limassol, , 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).
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.
FDF4APIGMP
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the methods and controls used in its manufacture and control do not appear to conform to current good manufacturing practices within the meaning of Section 501(a)(2)(B). This finished dosage form drug is made using an Active Pharmaceutical Ingredient from a facility that has been found non-compliant with current Good Manufacturing Practice (see Import Alert 66-40; http://www.accessdata.fda.gov/cms_ia/importalert_189.html). You may submit testimony to provide evidence to overcome the appearance of adulteration. The API source for this finished dosage form drug is:
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 3/29/2019 | 79GEIDEVICE, ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES | Division of Southeast Imports (DSEI) | |
| 11/20/2018 | 57YH02BLOOD BAGS WITH ANTI-COAGULANT PRIOR TO USE | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 10/16/2018 | 80LDQDEVICE, GENERAL MEDICAL | Division of Southeast Imports (DSEI) | |
| 9/26/2018 | 57YH02BLOOD BAGS WITH ANTI-COAGULANT PRIOR TO USE | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 3/15/2018 | 57YH02BLOOD BAGS WITH ANTI-COAGULANT PRIOR TO USE | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 8/8/2017 | 57YH02BLOOD BAGS WITH ANTI-COAGULANT PRIOR TO USE | 3847FDF4APIGMP | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is DEMOPHORIOUS LTD.'s FDA import refusal history?
DEMOPHORIOUS LTD. (FEI: 3013438661) has 6 FDA import refusal record(s) in our database, spanning from 8/8/2017 to 3/29/2019.
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. DEMOPHORIOUS LTD.'s FEI number is 3013438661.
What types of violations has DEMOPHORIOUS LTD. received?
DEMOPHORIOUS LTD. 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 DEMOPHORIOUS LTD. come from?
All FDA import refusal data for DEMOPHORIOUS 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.