LABORATORIO LA SANTE SA
⚠️ High Risk
FEI: 3012502199 • Bogota • COLOMBIA
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable violations.
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 |
|---|---|---|---|
| 12/1/2025 | 61FDK63RIFAXIMIN (A-BACTERIAL PT. I) (NOT ANTIBIOTIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/4/2019 | 60XCA02METOPROLOL (ANTI-ADRENERGIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/4/2019 | 62LCA40METRONIDAZOLE (ANTI-PROTOZOAL, A-LEISHMANIAL, A-MALARIAL) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/4/2019 | 56BCA03AMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/4/2017 | 56BDY03AMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is LABORATORIO LA SANTE SA's FDA import refusal history?
LABORATORIO LA SANTE SA (FEI: 3012502199) has 5 FDA import refusal record(s) in our database, spanning from 12/4/2017 to 12/1/2025.
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. LABORATORIO LA SANTE SA's FEI number is 3012502199.
What types of violations has LABORATORIO LA SANTE SA received?
LABORATORIO LA SANTE SA 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 LABORATORIO LA SANTE SA come from?
All FDA import refusal data for LABORATORIO LA SANTE SA 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.