Laboratorio Fito Medic`s S.A.S
⚠️ Moderate Risk
FEI: 3011365950 • Chinchina, Caldas • COLOMBIA
FEI Number
3011365950
Location
Chinchina, Caldas
Country
COLOMBIAAddress
Carrera 15 6 16, , Chinchina, Caldas, 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 |
|---|---|---|---|
| 6/17/2020 | 60JCY02ARGININE HCL (AMMONIA DETOXICANT) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/30/2018 | 62MBO08MENTHOL (ANTI-PRURITIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/30/2018 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Laboratorio Fito Medic`s S.A.S's FDA import refusal history?
Laboratorio Fito Medic`s S.A.S (FEI: 3011365950) has 3 FDA import refusal record(s) in our database, spanning from 8/30/2018 to 6/17/2020.
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. Laboratorio Fito Medic`s S.A.S's FEI number is 3011365950.
What types of violations has Laboratorio Fito Medic`s S.A.S received?
Laboratorio Fito Medic`s S.A.S 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 Fito Medic`s S.A.S come from?
All FDA import refusal data for Laboratorio Fito Medic`s S.A.S 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.