GENFAR S.A BOGOTA
⚠️ High Risk
FEI: 3012744939 • Bogota, Cundinamarca • COLOMBIA
FEI Number
3012744939
Location
Bogota, Cundinamarca
Country
COLOMBIAAddress
Carrera 20 # 44-70, , 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 |
|---|---|---|---|
| 6/12/2019 | 66VCY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/10/2019 | 65PDA03TAMSULOSIN HCL (REGULATOR) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/4/2019 | 60SCY27RABEPRAZOLE SODIUM (ANTACID) (ANTI-ULCER) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/19/2018 | 56BCE03AMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/13/2018 | 61HDY99ANTI-BACTERIAL, N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/4/2018 | 64BDY25HYDROCHLOROTHIAZIDE (DIURETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/4/2018 | 62ODY22CARVEDILOL (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/4/2018 | 62ODY14AMLODIPINE BESYLATE (ANTI-HYPERTENSIVE, PART II) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/4/2018 | 60LDY05ASPIRIN (ANALGESIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/21/2018 | 62OCF14AMLODIPINE BESYLATE (ANTI-HYPERTENSIVE, PART II) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/21/2018 | 62OCB14AMLODIPINE BESYLATE (ANTI-HYPERTENSIVE, PART II) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is GENFAR S.A BOGOTA's FDA import refusal history?
GENFAR S.A BOGOTA (FEI: 3012744939) has 11 FDA import refusal record(s) in our database, spanning from 3/21/2018 to 6/12/2019.
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.A BOGOTA's FEI number is 3012744939.
What types of violations has GENFAR S.A BOGOTA received?
GENFAR S.A BOGOTA 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 S.A BOGOTA come from?
All FDA import refusal data for GENFAR S.A BOGOTA 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.