Ethical Pharmaceutical
⚠️ Moderate Risk
FEI: 3004152473 • Santo Domingo • DOMINICAN REPUBLIC
FEI Number
3004152473
Location
Santo Domingo
Country
DOMINICAN REPUBLICAddress
Prolong. Av. 27 de Febrero. #1501, Alameda, Santo Domingo, , Dominican Republic
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 |
|---|---|---|---|
| 4/26/2019 | 66SDA27NIFEDIPINE (VASODILATOR) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/13/2011 | 65PCA02SILDENAFIL CITRATE (REGULATOR) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 11/5/2009 | 62KCA10OMEPRAZOLE (ANTI-PERISTALTIC, ANTI-DIARRHEAL) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 6/27/2008 | 61TCA11MECLIZINE HCL (ANTI-EMETIC/NAUSEANT) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 12/21/2006 | 60RCC19SIBUTRAMINE HCL MONOHYDRATE (ANOREXIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 12/21/2006 | 62CCA99ANTI-HYPERTENSIVE N.E.C. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 11/22/2006 | 60LCE99ANALGESIC, N.E.C. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 11/22/2006 | 60LCE99ANALGESIC, N.E.C. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 12/15/2005 | 62CCP99ANTI-HYPERTENSIVE N.E.C. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 11/4/2005 | 66VCY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 6/28/2005 | 62TCB02LANSOPRAZOLE (ANTI-SECRETORY) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Ethical Pharmaceutical's FDA import refusal history?
Ethical Pharmaceutical (FEI: 3004152473) has 11 FDA import refusal record(s) in our database, spanning from 6/28/2005 to 4/26/2019.
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. Ethical Pharmaceutical's FEI number is 3004152473.
What types of violations has Ethical Pharmaceutical received?
Ethical Pharmaceutical 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 Ethical Pharmaceutical come from?
All FDA import refusal data for Ethical Pharmaceutical 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.