Labs Gen Far
⚠️ Moderate Risk
FEI: 3008139706 • Parnamerican Cali • COLOMBIA
FEI Number
3008139706
Location
Parnamerican Cali
Country
COLOMBIAAddress
Far Kg 13 Via, , Parnamerican Cali, , 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
Frequently Asked Questions
What is Labs Gen Far's FDA import refusal history?
Labs Gen Far (FEI: 3008139706) has 2 FDA import refusal record(s) in our database, spanning from 6/20/2012 to 6/20/2012.
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. Labs Gen Far's FEI number is 3008139706.
What types of violations has Labs Gen Far received?
Labs Gen Far 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 Labs Gen Far come from?
All FDA import refusal data for Labs Gen Far 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.