Dragomir Emilian
⚠️ Moderate Risk
FEI: 3008907296 • Craiova, Dolj • ROMANIA
FEI Number
3008907296
Location
Craiova, Dolj
Country
ROMANIAAddress
Strada Bibescu Nr 31, Ap. 5, , Craiova, Dolj, Romania
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 |
|---|---|---|---|
| 5/16/2011 | 64BCA37SPIRONOLACTONE (DIURETIC) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 5/16/2011 | 64BCA24FUROSEMIDE (DIURETIC) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 5/16/2011 | 61JCA16ROSUVASTATIN CALCIUM | 75UNAPPROVED | New York District Office (NYK-DO) |
| 5/16/2011 | 62OCA27DOXAZOSIN MESYLATE (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 5/16/2011 | 62OCA05RAMIPRIL (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Dragomir Emilian's FDA import refusal history?
Dragomir Emilian (FEI: 3008907296) has 5 FDA import refusal record(s) in our database, spanning from 5/16/2011 to 5/16/2011.
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. Dragomir Emilian's FEI number is 3008907296.
What types of violations has Dragomir Emilian received?
Dragomir Emilian 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 Dragomir Emilian come from?
All FDA import refusal data for Dragomir Emilian 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.