Lab Bago
⚠️ Moderate Risk
FEI: 3011048650 • Quito, Pichincha • ECUADOR
FEI Number
3011048650
Location
Quito, Pichincha
Country
ECUADORAddress
Lizardo Garcia E 1080 Y Ave 12 De, , Quito, Pichincha, Ecuador
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 Lab Bago's FDA import refusal history?
Lab Bago (FEI: 3011048650) has 2 FDA import refusal record(s) in our database, spanning from 10/24/2014 to 4/24/2020.
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. Lab Bago's FEI number is 3011048650.
What types of violations has Lab Bago received?
Lab Bago 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 Lab Bago come from?
All FDA import refusal data for Lab Bago 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.