LABORATORIOS BIOFARMEX SA
⚠️ Moderate Risk
FEI: 3014377124 • Zapopan, COL • MEXICO
FEI Number
3014377124
Location
Zapopan, COL
Country
MEXICOAddress
La Haciendita 2085, , Zapopan, COL, Mexico
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
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).
NEW VET DR
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act in that it appears to be a new animal drug that is unsafe within the meaning of Section 512(a) of the Federal Food, Drug, and Cosmetic Act as it is not the subject of an approved new animal drug application, conditionally approved new animal drug application, or index listing, and no investigational new animal drug exemption applies.
Refusal History
Frequently Asked Questions
What is LABORATORIOS BIOFARMEX SA's FDA import refusal history?
LABORATORIOS BIOFARMEX SA (FEI: 3014377124) has 1 FDA import refusal record(s) in our database, spanning from 10/12/2023 to 10/12/2023.
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. LABORATORIOS BIOFARMEX SA's FEI number is 3014377124.
What types of violations has LABORATORIOS BIOFARMEX SA received?
LABORATORIOS BIOFARMEX SA 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 LABORATORIOS BIOFARMEX SA come from?
All FDA import refusal data for LABORATORIOS BIOFARMEX 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.