MEDLAB SOLUTIONS S A
⚠️ High Risk
FEI: 3034046420 • Medellin • COLOMBIA
FEI Number
3034046420
Location
Medellin
Country
COLOMBIAAddress
Av 34 56 90, , Medellin, , 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
NEW VET DR
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act in that it appears to be a new animal drug that is unsafe within the meaning of Section 512(a) of the Federal Food, Drug, and Cosmetic Act as it is not the subject of an approved new animal drug application, conditionally approved new animal drug application, or index listing, and no investigational new animal drug exemption applies.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 1/23/2025 | 62LQY40METRONIDAZOLE (ANTI-PROTOZOAL, A-LEISHMANIAL, A-MALARIAL) | 72NEW VET DR | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is MEDLAB SOLUTIONS S A's FDA import refusal history?
MEDLAB SOLUTIONS S A (FEI: 3034046420) has 1 FDA import refusal record(s) in our database, spanning from 1/23/2025 to 1/23/2025.
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. MEDLAB SOLUTIONS S A's FEI number is 3034046420.
What types of violations has MEDLAB SOLUTIONS S A received?
MEDLAB SOLUTIONS S A 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 MEDLAB SOLUTIONS S A come from?
All FDA import refusal data for MEDLAB SOLUTIONS S A 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.