MERCEDES VARGAS BERNAL
⚠️ Moderate Risk
FEI: 3014227633 • Cali, Valle Del Cauca • COLOMBIA
FEI Number
3014227633
Location
Cali, Valle Del Cauca
Country
COLOMBIAAddress
Carrera 95 46 -68, , Cali, Valle Del Cauca, 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 |
|---|---|---|---|
| 3/21/2018 | 62OCC41LOSARTAN POTASSIUM (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/21/2018 | 64GDB19ETHINYL ESTRADIOL (ESTROGEN) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/21/2018 | 64GCP13ESTRADIOL VALERATE (ESTROGEN) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/21/2018 | 62GCC49NAPROXEN (ANTI-INFLAMMATORY) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is MERCEDES VARGAS BERNAL's FDA import refusal history?
MERCEDES VARGAS BERNAL (FEI: 3014227633) has 4 FDA import refusal record(s) in our database, spanning from 3/21/2018 to 3/21/2018.
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. MERCEDES VARGAS BERNAL's FEI number is 3014227633.
What types of violations has MERCEDES VARGAS BERNAL received?
MERCEDES VARGAS BERNAL 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 MERCEDES VARGAS BERNAL come from?
All FDA import refusal data for MERCEDES VARGAS BERNAL 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.