HUGO JAVIER MONTERO
⚠️ Moderate Risk
FEI: 3013930509 • Bogota, Cundinamarca • COLOMBIA
FEI Number
3013930509
Location
Bogota, Cundinamarca
Country
COLOMBIAAddress
Carrera 118 N 80a-65 Casa 7, , 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
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 |
|---|---|---|---|
| 12/4/2017 | 61KIP22GLYCOPYRROLATE (ANTI-CHOLINERGIC) | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 12/4/2017 | 61FCB55CIPROFLOXACIN HYDROCHLORIDE (ANTI-BACTERIAL PART I) (NOT ANTIBIOTIC) | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 12/4/2017 | 62GCB18DICLOFENAC SODIUM (ANTI-INFLAMMATORY) | 118NOT LISTED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is HUGO JAVIER MONTERO's FDA import refusal history?
HUGO JAVIER MONTERO (FEI: 3013930509) has 3 FDA import refusal record(s) in our database, spanning from 12/4/2017 to 12/4/2017.
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. HUGO JAVIER MONTERO's FEI number is 3013930509.
What types of violations has HUGO JAVIER MONTERO received?
HUGO JAVIER MONTERO 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 HUGO JAVIER MONTERO come from?
All FDA import refusal data for HUGO JAVIER MONTERO 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.