Labs Lasante
⚠️ Moderate Risk
FEI: 3004707008 • Bogota, Cundinamarca • COLOMBIA
FEI Number
3004707008
Location
Bogota, Cundinamarca
Country
COLOMBIAAddress
Calle 16 N 32-34, , Bogota, Cundinamarca, Colombia
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).
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
| Date | Product | Violations | Division |
|---|---|---|---|
| 10/24/2014 | 64BCB25HYDROCHLOROTHIAZIDE (DIURETIC) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 10/24/2014 | 61JCB12LOVASTATIN (ANTI-CHOLESTEREMIC) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 10/24/2014 | 66JCB01LEVOTHYROXINE SODIUM (THYROID HORMONE) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 10/24/2014 | 62KCB10OMEPRAZOLE (ANTI-PERISTALTIC, ANTI-DIARRHEAL) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 10/24/2014 | 60SAA01ALGELDRATE (ANTACID) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 10/24/2014 | 62OCB14AMLODIPINE BESYLATE (ANTI-HYPERTENSIVE, PART II) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 10/24/2014 | 62OCB41LOSARTAN POTASSIUM (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 3/12/2014 | 68YYY10SMALL ANIMAL ANIMAL DRUGS N.E.C. | 72NEW VET DR | Cincinnati District Office (CIN-DO) |
| 3/12/2014 | 68YYY10SMALL ANIMAL ANIMAL DRUGS N.E.C. | 72NEW VET DR | Cincinnati District Office (CIN-DO) |
| 8/29/2006 | 62KCF10OMEPRAZOLE (ANTI-PERISTALTIC, ANTI-DIARRHEAL) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Labs Lasante's FDA import refusal history?
Labs Lasante (FEI: 3004707008) has 10 FDA import refusal record(s) in our database, spanning from 8/29/2006 to 10/24/2014.
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. Labs Lasante's FEI number is 3004707008.
What types of violations has Labs Lasante received?
Labs Lasante has been cited for 2 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 Labs Lasante come from?
All FDA import refusal data for Labs Lasante 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.