Laboratorios Farmaceuticos Loren S.A. DE C.V.
⚠️ High Risk
FEI: 3004060753 • Pueblo Huejotingo • MEXICO
FEI Number
3004060753
Location
Pueblo Huejotingo
Country
MEXICOAddress
Km. 91 Carretera Federal Mexico, , Pueblo Huejotingo, , 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 |
|---|---|---|---|
| 10/14/2025 | 64LQY19DEXAMETHASONE (GLUCOCORTICOID) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Laboratorios Farmaceuticos Loren S.A. DE C.V.'s FDA import refusal history?
Laboratorios Farmaceuticos Loren S.A. DE C.V. (FEI: 3004060753) has 1 FDA import refusal record(s) in our database, spanning from 10/14/2025 to 10/14/2025.
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. Laboratorios Farmaceuticos Loren S.A. DE C.V.'s FEI number is 3004060753.
What types of violations has Laboratorios Farmaceuticos Loren S.A. DE C.V. received?
Laboratorios Farmaceuticos Loren S.A. DE C.V. 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 Laboratorios Farmaceuticos Loren S.A. DE C.V. come from?
All FDA import refusal data for Laboratorios Farmaceuticos Loren S.A. DE C.V. 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.