MARIA DEL SOCORRO ALVAREZ MARIN
⚠️ Moderate Risk
FEI: 3014213458 • Armenia, Quindio • COLOMBIA
FEI Number
3014213458
Location
Armenia, Quindio
Country
COLOMBIAAddress
Km 4 Via El Caimo Condel Verd, , Armenia, Quindio, Colombia
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 |
|---|---|---|---|
| 3/8/2018 | 62ODC37IRBESARTAN (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/8/2018 | 62ODC24DILTIAZEM HYDROCHLORIDE (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/8/2018 | 60LAC01ACETAMINOPHEN (ANALGESIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is MARIA DEL SOCORRO ALVAREZ MARIN's FDA import refusal history?
MARIA DEL SOCORRO ALVAREZ MARIN (FEI: 3014213458) has 3 FDA import refusal record(s) in our database, spanning from 3/8/2018 to 3/8/2018.
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. MARIA DEL SOCORRO ALVAREZ MARIN's FEI number is 3014213458.
What types of violations has MARIA DEL SOCORRO ALVAREZ MARIN received?
MARIA DEL SOCORRO ALVAREZ MARIN 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 MARIA DEL SOCORRO ALVAREZ MARIN come from?
All FDA import refusal data for MARIA DEL SOCORRO ALVAREZ MARIN 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.