GENFAR SANOFI
⚠️ High Risk
FEI: 3013021544 • Bogata • 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 |
|---|---|---|---|
| 4/10/2025 | 65RDL12POTASSIC SALINE (INJECTION) (REPLENISHER) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/10/2025 | 56IDA76AZITHROMYCIN (MACAROLIDES) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/10/2025 | 60LDA01ACETAMINOPHEN (ANALGESIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/10/2025 | 56JDJ99LINCOMYCIN N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/10/2025 | 61WDA45FLUCONAZOLE (ANTI-FUNGAL) (NOT ANTIBIOTIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/5/2022 | 62YCY07MELOXICAM (ANTI-INFLAMMATORY, PART II) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/2/2021 | 62OCE14AMLODIPINE BESYLATE (ANTI-HYPERTENSIVE, PART II) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/21/2020 | 62OCY14AMLODIPINE BESYLATE (ANTI-HYPERTENSIVE, PART II) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/20/2018 | 60LDE69TRAMADOL HCL (ANALGESIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/20/2018 | 62GDA99ANTI-INFLAMMATORY N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/20/2018 | 56JDE20CLINDAMYCIN HYDROCHLORIDE HYDRATE (LINCOMYCINS) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/20/2018 | 56DDE06AMIKACIN SULFATE (AMINOGLYCOSIDES) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is GENFAR SANOFI's FDA import refusal history?
GENFAR SANOFI (FEI: 3013021544) has 12 FDA import refusal record(s) in our database, spanning from 4/20/2018 to 4/10/2025.
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 SANOFI's FEI number is 3013021544.
What types of violations has GENFAR SANOFI received?
GENFAR SANOFI 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 SANOFI come from?
All FDA import refusal data for GENFAR SANOFI 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.