FRANCO COLOMBIAN LABORATORY
⚠️ High Risk
FEI: 3030735153 • Valle Del Cauca • COLOMBIA
FEI Number
3030735153
Location
Valle Del Cauca
Country
COLOMBIAAddress
Cra. 1 #84 46a, La Alia, , Valle Del Cauca, , 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
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 FRANCO COLOMBIAN LABORATORY's FDA import refusal history?
FRANCO COLOMBIAN LABORATORY (FEI: 3030735153) has 2 FDA import refusal record(s) in our database, spanning from 6/26/2024 to 6/26/2024.
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. FRANCO COLOMBIAN LABORATORY's FEI number is 3030735153.
What types of violations has FRANCO COLOMBIAN LABORATORY received?
FRANCO COLOMBIAN LABORATORY 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 FRANCO COLOMBIAN LABORATORY come from?
All FDA import refusal data for FRANCO COLOMBIAN LABORATORY 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.