Our Dream House Roger Meilak
⚠️ Moderate Risk
FEI: 3010686521 • Nadur • MALTA
FEI Number
3010686521
Location
Nadur
Country
MALTAAddress
Triq Guze' Ellul Mercer, , Nadur, , Malta
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).
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 |
|---|---|---|---|
| 3/31/2014 | 61NCA65CITALOPRAM HYDROBROMIDE (ANTI-DEPRESSANT) | Division of Northeast Imports (DNEI) | |
| 3/31/2014 | 61LCA99ANTI-COAGULANT, N.E.C. | Division of Northeast Imports (DNEI) | |
| 3/31/2014 | 62OCA12VALSARTAN (ANTI-HYPERTENSIVE - PART II) | Division of Northeast Imports (DNEI) |
Frequently Asked Questions
What is Our Dream House Roger Meilak's FDA import refusal history?
Our Dream House Roger Meilak (FEI: 3010686521) has 3 FDA import refusal record(s) in our database, spanning from 3/31/2014 to 3/31/2014.
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. Our Dream House Roger Meilak's FEI number is 3010686521.
What types of violations has Our Dream House Roger Meilak received?
Our Dream House Roger Meilak has been cited for 2 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 Our Dream House Roger Meilak come from?
All FDA import refusal data for Our Dream House Roger Meilak 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.