Laboratorio Franco Colombiano Lafrancol S.A.
⚠️ High Risk
FEI: 3004399994 • Cali, Valle Del Cauca • COLOMBIA
FEI Number
3004399994
Location
Cali, Valle Del Cauca
Country
COLOMBIAAddress
Barrio La Alianza, Carrera 1 No. 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).
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 7/12/2023 | 66SCA51TADALAFIL | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/29/2021 | 61JDY08ATORVASTATIN CALCIUM (ANTI-CHOLESTEREMIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/27/2020 | 66VCY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/3/2020 | 61BDA99ANTI-ANDROGEN, N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/29/2020 | 62UDA13HYDROCODONE BITARTRATE (ANTI-TUSSIVE/COLD) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/12/2020 | 64GDB03DIENESTROL (ESTROGEN) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/20/2019 | 66VCA99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/14/2018 | 61NCE66FLUOXETINE HYDROCHLORIDE (ANTI-DEPRESSANT) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/14/2016 | 61NCA29FLUOXETINE (ANTI-DEPRESSANT) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 9/14/2016 | 62OCS29ENALAPRILATE (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 9/14/2016 | 62KCF10OMEPRAZOLE (ANTI-PERISTALTIC, ANTI-DIARRHEAL) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 10/27/2011 | 64GDP11ESTRADIOL ENANTHATE (ESTROGEN) | New Orleans District Office (NOL-DO) | |
| 8/19/2011 | 64GDB07ESTRADIOL (ESTROGEN) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 11/5/2009 | 62ODP28ENALAPRIL MALEATE (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 6/30/2008 | 65PCA02SILDENAFIL CITRATE (REGULATOR) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 4/28/2005 | 63XDY99DIAGOSTIC AID (DRUGS) N.E.C. | Florida District Office (FLA-DO) |
Frequently Asked Questions
What is Laboratorio Franco Colombiano Lafrancol S.A.'s FDA import refusal history?
Laboratorio Franco Colombiano Lafrancol S.A. (FEI: 3004399994) has 16 FDA import refusal record(s) in our database, spanning from 4/28/2005 to 7/12/2023.
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. Laboratorio Franco Colombiano Lafrancol S.A.'s FEI number is 3004399994.
What types of violations has Laboratorio Franco Colombiano Lafrancol S.A. received?
Laboratorio Franco Colombiano Lafrancol S.A. 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 Laboratorio Franco Colombiano Lafrancol S.A. come from?
All FDA import refusal data for Laboratorio Franco Colombiano Lafrancol S.A. 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.