Ivax Pharmaceutical Mexico
⚠️ Moderate Risk
FEI: 3004622712 • Tlalpan • MEXICO
FEI Number
3004622712
Location
Tlalpan
Country
MEXICOAddress
Calzada De Tlalpan, , Tlalpan, , 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).
Refusal History
Frequently Asked Questions
What is Ivax Pharmaceutical Mexico's FDA import refusal history?
Ivax Pharmaceutical Mexico (FEI: 3004622712) has 2 FDA import refusal record(s) in our database, spanning from 3/30/2005 to 3/30/2005.
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. Ivax Pharmaceutical Mexico's FEI number is 3004622712.
What types of violations has Ivax Pharmaceutical Mexico received?
Ivax Pharmaceutical Mexico 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 Ivax Pharmaceutical Mexico come from?
All FDA import refusal data for Ivax Pharmaceutical Mexico 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.