Remedica Ltd
⚠️ Moderate Risk
FEI: 3004452413 • Lemesos, Lemesos • CYPRUS
FEI Number
3004452413
Location
Lemesos, Lemesos
Country
CYPRUSAddress
Industrial East, , 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
UNAPPROVED
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 7/23/2008 | 62GAO99ANTI-INFLAMMATORY N.E.C. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 9/1/2006 | 60XCP17ATENOLOL (ANTI-ADRENERGIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 4/22/2005 | 61WDY04CLOTRIMAZOLE (ANTI-FUNGAL) (NOT ANTIBIOTIC) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 4/22/2005 | 56EDY22DOXYCYCLINE HYCLATE (TETRACYCLINES) | 75UNAPPROVED | Florida District Office (FLA-DO) |
Frequently Asked Questions
What is Remedica Ltd's FDA import refusal history?
Remedica Ltd (FEI: 3004452413) has 4 FDA import refusal record(s) in our database, spanning from 4/22/2005 to 7/23/2008.
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. Remedica Ltd's FEI number is 3004452413.
What types of violations has Remedica Ltd received?
Remedica Ltd has been cited for 1 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 Remedica Ltd come from?
All FDA import refusal data for Remedica 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.