Laboratorios Laproff S.A.
⚠️ High Risk
FEI: 3010827055 • Sabaneta, Antioquia • COLOMBIA
FEI Number
3010827055
Location
Sabaneta, Antioquia
Country
COLOMBIAAddress
Cra. 43A #61 Sur-84, Alto Las Flores, , Sabaneta, Antioquia, 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).
NOT LISTED
It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 9/3/2025 | 62GCA49NAPROXEN (ANTI-INFLAMMATORY) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/24/2025 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/24/2025 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/2/2024 | 62ODA41LOSARTAN POTASSIUM (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/15/2023 | 61GCB84NORFLOXACIN (ANTI-BACTERIAL, PART II) (NOT ANTIBIOTIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/18/2022 | 64BDY24FUROSEMIDE (DIURETIC) | Division of Southeast Imports (DSEI) | |
| 2/11/2022 | 61NCY29FLUOXETINE (ANTI-DEPRESSANT) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/8/2020 | 64BCY24FUROSEMIDE (DIURETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/4/2019 | 62OCA41LOSARTAN POTASSIUM (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/2/2019 | 66FDA05COLCHICINE (SUPPRESSANT) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/17/2019 | 62JCA99ANTI-PARKINSONIAN N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/17/2019 | 61TAA29SCOPOLAMINE (ANTI-EMETIC/NAUSEANT) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/30/2019 | 61XCA45CETIRIZINE HYDROCHLORIDE (ANTI-HISTAMINIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/30/2019 | 61ECA08LORATADINE (ANTI-ASTHMATIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/21/2018 | 62OCB14AMLODIPINE BESYLATE (ANTI-HYPERTENSIVE, PART II) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/10/2017 | 62GCA49NAPROXEN (ANTI-INFLAMMATORY) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/5/2015 | 64BCA24FUROSEMIDE (DIURETIC) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is Laboratorios Laproff S.A.'s FDA import refusal history?
Laboratorios Laproff S.A. (FEI: 3010827055) has 17 FDA import refusal record(s) in our database, spanning from 11/5/2015 to 9/3/2025.
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. Laboratorios Laproff S.A.'s FEI number is 3010827055.
What types of violations has Laboratorios Laproff S.A. received?
Laboratorios Laproff 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 Laboratorios Laproff S.A. come from?
All FDA import refusal data for Laboratorios Laproff 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.