LAL HOLDING EMPRESARIAL
⚠️ High Risk
FEI: 3040061112 • Medellin, Antioquia • COLOMBIA
FEI Number
3040061112
Location
Medellin, Antioquia
Country
COLOMBIAAddress
Cl 50 43 26, , Medellin, Antioquia, 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
NOT LISTED
It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
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 LAL HOLDING EMPRESARIAL's FDA import refusal history?
LAL HOLDING EMPRESARIAL (FEI: 3040061112) has 2 FDA import refusal record(s) in our database, spanning from 12/8/2025 to 12/12/2025.
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. LAL HOLDING EMPRESARIAL's FEI number is 3040061112.
What types of violations has LAL HOLDING EMPRESARIAL received?
LAL HOLDING EMPRESARIAL has been cited for 3 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 LAL HOLDING EMPRESARIAL come from?
All FDA import refusal data for LAL HOLDING EMPRESARIAL 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.