RAMOS LABORATORIES SA
⚠️ High Risk
FEI: 3040987361 • Managua, Managua • NICARAGUA
FEI Number
3040987361
Location
Managua, Managua
Country
NICARAGUAAddress
P 4 Edificio Ramos Fren, , Managua, Managua, Nicaragua
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
Frequently Asked Questions
What is RAMOS LABORATORIES SA's FDA import refusal history?
RAMOS LABORATORIES SA (FEI: 3040987361) has 2 FDA import refusal record(s) in our database, spanning from 12/5/2025 to 12/5/2025.
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. RAMOS LABORATORIES SA's FEI number is 3040987361.
What types of violations has RAMOS LABORATORIES SA received?
RAMOS LABORATORIES 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 RAMOS LABORATORIES SA come from?
All FDA import refusal data for RAMOS LABORATORIES 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.