Laboratorios Leti
⚠️ Moderate Risk
FEI: 3004576565 • Caracas, D.F. • VENEZUELA
FEI Number
3004576565
Location
Caracas, D.F.
Country
VENEZUELAAddress
Apartado 1722, , Caracas, D.F., Venezuela
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
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 |
|---|---|---|---|
| 12/2/2019 | 62GDA90DICLOFENAC POTASSIUM (ANTI-INFLAMMATORY) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/2/2019 | 62ODA41LOSARTAN POTASSIUM (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/27/2011 | 61HCA43LEVOFLOXACIN (ANTI-BACTERIAL, PART III) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 9/15/2005 | 62OCA29ENALAPRILATE (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/14/2005 | 62CCA65LISINOPRIL (ANTI-HYPERTENSIVE) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Laboratorios Leti's FDA import refusal history?
Laboratorios Leti (FEI: 3004576565) has 5 FDA import refusal record(s) in our database, spanning from 3/14/2005 to 12/2/2019.
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 Leti's FEI number is 3004576565.
What types of violations has Laboratorios Leti received?
Laboratorios Leti 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 Leti come from?
All FDA import refusal data for Laboratorios Leti 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.