Lafrancol sa
⚠️ High Risk
FEI: 2000020548 • Cali, Valle Del Cauca • COLOMBIA
FEI Number
2000020548
Location
Cali, Valle Del Cauca
Country
COLOMBIAAddress
Carrera 1 46-84, , Cali, Valle Del Cauca, 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 |
|---|---|---|---|
| 10/24/2025 | 62GBA50NAPROXEN SODIUM (ANTI-INFLAMMATORY) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/13/2021 | 64GDA29LEVONORGESTREL (ESTROGEN) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/1/2020 | 66VCY99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Southeast Imports (DSEI) | |
| 9/18/2020 | 62VCO29IMIQUIMOD (ANTI-VIRAL) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/4/2020 | 60RCY18ORLISTAT/TETRAHYDROLIPSTATIN (ANOREXIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/16/2020 | 62ODA28ENALAPRIL MALEATE (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/24/2018 | 64GCY19ETHINYL ESTRADIOL (ESTROGEN) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Lafrancol sa's FDA import refusal history?
Lafrancol sa (FEI: 2000020548) has 7 FDA import refusal record(s) in our database, spanning from 8/24/2018 to 10/24/2025.
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. Lafrancol sa's FEI number is 2000020548.
What types of violations has Lafrancol sa received?
Lafrancol sa has been cited for 2 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 Lafrancol sa come from?
All FDA import refusal data for Lafrancol sa 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.