LA SANTE
⚠️ Moderate Risk
FEI: 3013154056 • Bogota • COLOMBIA
FEI Number
3013154056
Location
Bogota
Country
COLOMBIAAddress
A17a 93 Cra 32 17a1, , Bogota, , 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).
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
| Date | Product | Violations | Division |
|---|---|---|---|
| 2/18/2022 | 61JDY16ROSUVASTATIN CALCIUM | Division of Southeast Imports (DSEI) | |
| 8/24/2020 | 62ODA41LOSARTAN POTASSIUM (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/12/2019 | 66VCY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/23/2018 | 65PCA02SILDENAFIL CITRATE (REGULATOR) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is LA SANTE's FDA import refusal history?
LA SANTE (FEI: 3013154056) has 4 FDA import refusal record(s) in our database, spanning from 4/23/2018 to 2/18/2022.
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. LA SANTE's FEI number is 3013154056.
What types of violations has LA SANTE received?
LA SANTE 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 LA SANTE come from?
All FDA import refusal data for LA SANTE 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.