Laboratorios de Aplicaciones Medicas SRL
⚠️ Moderate Risk
FEI: 3004448641 • Santo Domingo • DOMINICAN REPUBLIC
FEI Number
3004448641
Location
Santo Domingo
Country
DOMINICAN REPUBLICAddress
Gustavo Mejia Ricar, Abraham Lincon Esq., 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 |
|---|---|---|---|
| 5/7/2020 | 62ODY19CANDESARTAN CILEXETIL (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/24/2016 | 62ODB28ENALAPRIL MALEATE (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 8/24/2016 | 62ODB28ENALAPRIL MALEATE (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 4/25/2012 | 66FCA05COLCHICINE (SUPPRESSANT) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 7/18/2005 | 66VDO99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 2/3/2005 | 64HCK01BROMHEXINE HCL (EXPECTORANT) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Laboratorios de Aplicaciones Medicas SRL's FDA import refusal history?
Laboratorios de Aplicaciones Medicas SRL (FEI: 3004448641) has 6 FDA import refusal record(s) in our database, spanning from 2/3/2005 to 5/7/2020.
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. Laboratorios de Aplicaciones Medicas SRL's FEI number is 3004448641.
What types of violations has Laboratorios de Aplicaciones Medicas SRL received?
Laboratorios de Aplicaciones Medicas SRL 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 Laboratorios de Aplicaciones Medicas SRL come from?
All FDA import refusal data for Laboratorios de Aplicaciones Medicas SRL 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.