JAIME ANDRES CASTANEDA VELASQUEZ
⚠️ Moderate Risk
FEI: 3018252694 • Cali, Valle Del Cauca • COLOMBIA
FEI Number
3018252694
Location
Cali, Valle Del Cauca
Country
COLOMBIAAddress
Avenida 9n 10n 107, , Cali, Valle Del Cauca, 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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 4/26/2021 | 56ECY99TETRACYCLINE N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/26/2021 | 62HCA03TROVAFLOXACIN/AZITHROMYCIN (ANTI-MICROBIAL) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/26/2021 | 64LCA03BETAMETHASONE (GLUCOCORTICOID) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/26/2021 | 62LCA47IVERMECTIN (ANTI-PROTOZOAL, A-LEISHMANIAL, ANTI-MALARIAL) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is JAIME ANDRES CASTANEDA VELASQUEZ's FDA import refusal history?
JAIME ANDRES CASTANEDA VELASQUEZ (FEI: 3018252694) has 4 FDA import refusal record(s) in our database, spanning from 4/26/2021 to 4/26/2021.
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. JAIME ANDRES CASTANEDA VELASQUEZ's FEI number is 3018252694.
What types of violations has JAIME ANDRES CASTANEDA VELASQUEZ received?
JAIME ANDRES CASTANEDA VELASQUEZ 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 JAIME ANDRES CASTANEDA VELASQUEZ come from?
All FDA import refusal data for JAIME ANDRES CASTANEDA VELASQUEZ 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.