Genfar
⚠️ High Risk
FEI: 3009499098 • Bogota, Distrito Capital • COLOMBIA
FEI Number
3009499098
Location
Bogota, Distrito Capital
Country
COLOMBIAAddress
Calle 44 20a 70, , Bogota, Distrito Capital, 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 |
|---|---|---|---|
| 1/3/2022 | 56DRP06AMIKACIN SULFATE (AMINOGLYCOSIDES) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/3/2022 | 64LRP19DEXAMETHASONE (GLUCOCORTICOID) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/29/2021 | 61JDY08ATORVASTATIN CALCIUM (ANTI-CHOLESTEREMIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/29/2021 | 64BDY25HYDROCHLOROTHIAZIDE (DIURETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/25/2018 | 60LDB01ACETAMINOPHEN (ANALGESIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/25/2018 | 61WBC45FLUCONAZOLE (ANTI-FUNGAL) (NOT ANTIBIOTIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/25/2018 | 62GCL90DICLOFENAC POTASSIUM (ANTI-INFLAMMATORY) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/25/2018 | 62GCL59PIROXICAM (ANTI-INFLAMMATORY) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/25/2018 | 61PCB11GLYBURIDE (ANTI-DIABETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/25/2018 | 62OCB37IRBESARTAN (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/25/2018 | 60WCB16MEBENDAZOLE (ANTHELMINTIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Genfar's FDA import refusal history?
Genfar (FEI: 3009499098) has 11 FDA import refusal record(s) in our database, spanning from 5/25/2018 to 1/3/2022.
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. Genfar's FEI number is 3009499098.
What types of violations has Genfar received?
Genfar 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 Genfar come from?
All FDA import refusal data for Genfar 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.