JOSE JAVIER PALOMA
⚠️ High Risk
FEI: 3014195543 • Bogota, Cundinamarca • COLOMBIA
FEI Number
3014195543
Location
Bogota, Cundinamarca
Country
COLOMBIAAddress
Calle 69 46, B, Bogota, Cundinamarca, Colombia
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable violations.
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 |
|---|---|---|---|
| 2/22/2018 | 62GCB18DICLOFENAC SODIUM (ANTI-INFLAMMATORY) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/22/2018 | 61ECB09MONTELUKAST SODIUM (ANTI-ASTHMATIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/22/2018 | 61ECQ99ANTI-ASTHMATIC, N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/22/2018 | 61PCB55METFORMIN HCL (ANTI-DIABETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/22/2018 | 62UDB07CODEINE (ANTI-TUSSIVE/COLD) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/22/2018 | 62OCB14AMLODIPINE BESYLATE (ANTI-HYPERTENSIVE, PART II) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/22/2018 | 60LAB05ASPIRIN (ANALGESIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/22/2018 | 61JCB08ATORVASTATIN CALCIUM (ANTI-CHOLESTEREMIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/22/2018 | 62OCB41LOSARTAN POTASSIUM (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/22/2018 | 62OCB23CLONIDINE (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/22/2018 | 62ODB44METOPROLOL TARTRATE (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/22/2018 | 62KCB05LOPERAMIDE (ANTI-PERISTALTIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/22/2018 | 66JDB01LEVOTHYROXINE SODIUM (THYROID HORMONE) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/22/2018 | 63HDK25POLYETHYLENE GLYCOL 3350/ELECTROLYTES (CARTHARTIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/22/2018 | 64DAL01CARBOXYMETHYLCELLULOSE SODIUM, EMOLLIENT,LUBRICANT | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/22/2018 | 62TCB06ESOMEPRAZOLE MAGNESIUM (ANTI-SECRETORY) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/22/2018 | 61TCB31DOMPERIDONE | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is JOSE JAVIER PALOMA's FDA import refusal history?
JOSE JAVIER PALOMA (FEI: 3014195543) has 17 FDA import refusal record(s) in our database, spanning from 2/22/2018 to 2/22/2018.
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. JOSE JAVIER PALOMA's FEI number is 3014195543.
What types of violations has JOSE JAVIER PALOMA received?
JOSE JAVIER PALOMA 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 JOSE JAVIER PALOMA come from?
All FDA import refusal data for JOSE JAVIER PALOMA 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.