Winthrop Pharmaceuticals
⚠️ Moderate Risk
FEI: 3011014265 • Medellin • COLOMBIA
FEI Number
3011014265
Location
Medellin
Country
COLOMBIAAddress
Carrera 43 A 1 Sur De 301, , Medellin, , Colombia
Moderate Risk
FDA Import Risk Assessment
This firm has a moderate history of FDA import refusals. Some attention may be warranted.
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 |
|---|---|---|---|
| 10/7/2015 | 60LDB05ASPIRIN (ANALGESIC) | Florida District Office (FLA-DO) | |
| 1/30/2015 | 61PCB26METFORMIN (ANTI-DIABETIC) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 10/8/2014 | 61PCB11GLYBURIDE (ANTI-DIABETIC) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 10/8/2014 | 61WAO45FLUCONAZOLE (ANTI-FUNGAL) (NOT ANTIBIOTIC) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 10/8/2014 | 56BCB03AMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 10/8/2014 | 61PCB26METFORMIN (ANTI-DIABETIC) | 75UNAPPROVED | Florida District Office (FLA-DO) |
Frequently Asked Questions
What is Winthrop Pharmaceuticals's FDA import refusal history?
Winthrop Pharmaceuticals (FEI: 3011014265) has 6 FDA import refusal record(s) in our database, spanning from 10/8/2014 to 10/7/2015.
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. Winthrop Pharmaceuticals's FEI number is 3011014265.
What types of violations has Winthrop Pharmaceuticals received?
Winthrop Pharmaceuticals 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 Winthrop Pharmaceuticals come from?
All FDA import refusal data for Winthrop Pharmaceuticals 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.