JOSE MANUEL OLARTE NAJERA
⚠️ High Risk
FEI: 3035364605 • Heroica Puebla De Zaragoza, Puebla • MEXICO
FEI Number
3035364605
Location
Heroica Puebla De Zaragoza, Puebla
Country
MEXICOAddress
Privada 2da Universidad De Baja California 6713, Col. Universidades, Puebla, Heroica Puebla De Zaragoza, Puebla, Mexico
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
| Date | Product | Violations | Division |
|---|---|---|---|
| 3/6/2025 | 62LCY34PYRIMETHAMINE (ANTI-PROTOZOAL, A-LEISHMANIAL, A-MALARIAL) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is JOSE MANUEL OLARTE NAJERA's FDA import refusal history?
JOSE MANUEL OLARTE NAJERA (FEI: 3035364605) has 1 FDA import refusal record(s) in our database, spanning from 3/6/2025 to 3/6/2025.
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. JOSE MANUEL OLARTE NAJERA's FEI number is 3035364605.
What types of violations has JOSE MANUEL OLARTE NAJERA received?
JOSE MANUEL OLARTE NAJERA 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 JOSE MANUEL OLARTE NAJERA come from?
All FDA import refusal data for JOSE MANUEL OLARTE NAJERA 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.