NOVARTIS COLOMBIA
⚠️ Moderate Risk
FEI: 3013636377 • Bogota • COLOMBIA
FEI Number
3013636377
Location
Bogota
Country
COLOMBIAAddress
Calle 93b N 16-31, , Bogota, , 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
Frequently Asked Questions
What is NOVARTIS COLOMBIA's FDA import refusal history?
NOVARTIS COLOMBIA (FEI: 3013636377) has 2 FDA import refusal record(s) in our database, spanning from 4/20/2018 to 5/8/2020.
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. NOVARTIS COLOMBIA's FEI number is 3013636377.
What types of violations has NOVARTIS COLOMBIA received?
NOVARTIS COLOMBIA 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 NOVARTIS COLOMBIA come from?
All FDA import refusal data for NOVARTIS COLOMBIA 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.